Certification of Death (Scotland) Act 2011: statutory guidance
Key operational principles for the purposes of the Certification of Death (Scotland) Act 2011.
Part 2 - Guidance on the Review Process and Types of Reviews
2.1 Overview
2.1.1 Section 2 of the 2011 Act sets out that the Registrar General for Scotland must ensure that a random selection of Medical Certificates of Cause of Death (MCCDs) are referred for review; and section 8 provides that a medical reviewer must review any MCCD so referred.
2.1.2 Under the terms of the 2011 Act, the new review process commences when the informant visits the registrar to register a death. The registrar will enter the relevant information into the National Records of Scotland registration system (the Forward Electronic Register system or "FER"). FER will automatically and randomly highlight if the case is one that is to be referred for review. If the MCCD was completed electronically the relevant information will have been automatically entered into FER at the time of completion. FER will automatically and randomly highlight if the case is one that has already been referred for review.
2.1.3 When a case is selected for review the registrar will advise the informant of this and that they will be contacted and / or sent the Certificate of Registration of Death (Form 14 or "death certificate") once the review has been completed. The review will be undertaken by one of the nationally appointed medical reviewers and it is expected that informants will normally be contacted by the registrar, with the outcome of the review within one to three working days. If the MCCD was completed electronically it may be that the review process will have been completed by the time the informant arrives to register the death.
2.1.4 The vast majority of reviews will be 'Level 1' reviews, which involve checking the MCCD and 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 still that these reviews will be completed within three working days.
2.1.5 The 2011 Act does not set out how many MCCDs should be referred to medical reviewers nor what exactly a review might encompass. This was to ensure that the legislation is sufficiently flexible to allow the system of scrutiny to be reviewed and amended over time, if needed. This Guidance therefore sets down more detail on how the random sampling of MCCDs will be undertaken and how Medical Reviewers will undertake the reviews under the 2011 Act.
2.2 Random Sampling
2.2.1 Under section 2 of the 2011 Act, Scottish Ministers may give directions to the Registrar General in relation to the referral of certificates for review. No such directions have been required or issued to date. Instead this Guidance sets out the Registrar General's and Scottish Minister's shared expectations as to how certificates will be selected and referred for review.
2.2.2 National Records of Scotland will implement procedures to ensure that a random sample of MCCDs are selected and referred by registrars for review by medical reviewers. These cases will be selected at the point of registration of death by the informant, in the registrar's office, during / following the input of the applicable MCCD details into FER, or when the eMCCD is transmitted to FER.
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 introduces 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 2011 Act sets out specific instances where an 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 under section 2 of the 2011 Act.[1]
2.2.5 Still-birth certificates will not be referred for review under the new system and there is no change to the role of the Crown Office and Procurator Fiscal Service (COPFS) or associated processes.
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, supported by medical reviewers' assistants. The senior medical reviewer and medical reviewers must be employed by Healthcare Improvement Scotland.
2.3.2 Under section 21 the 2011 Act, the medical profession has a duty to co-operate with medical reviewers and senior medical reviewer, in order that they can fulfil their functions in these roles.[2]
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 this basis of this statutory guidance, the senior medical reviewer and medical reviewers will therefore be undertaking the following types of review:
2.4 Level 1 Reviews
2.4.1 The main purpose of Level 1 reviews is for the deterrence of poor practice and malpractice, for public reassurance and for quality improvement and quality assurance. Level 1 reviews will include the review of the underlying cause of death and other conditions recorded on the MCCD, including the timeline, and will query anything unusual or unexpected.
2.4.2 This will involve checking 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. Level 1 reviews will allow for any discrepancies to be picked up and, at the discretion of the medical reviewer, can act as a trigger for a 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 certifying doctor and registration of death (or as otherwise commenced e.g. by an eMCCD) triggers a Level 1 review | |
| 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 randomised and the review is either underway or has been completed, the registrar will provide the information 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 scanned and 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 death certification review service (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 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 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, and the registrar will inform the outcome of the review to the Informant as well as 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 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: http://www.legislation.gov.uk/asp/2011/11/section/10 In brief, the medical reviewer and the certifying doctor will explore options including amending (by means of a signed and dated note/email attached to the original MCCD, or an annotated and initialled 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 able to conclude (see Step 5), or 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[3] In brief, the senior medical reviewer may re-review the case again with the certifying doctor and if there is still no agreement, may decide the review is completed (see Step 5). 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. |
2.5 Level 2 Reviews
2.5.1 The main purpose of a Level 2 review is to provide information for the quality improvement elements of the new death certification system; a secondary purpose is to provide a route, if required, for the more comprehensive examination of a Level 1 review; and a further purpose is to provide a certain 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 as to 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 suitable means such as, 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 legal requirement will provide reassurance to the certifying doctors about patient confidentiality issues.[4]
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 certifying doctor and registration of death (or as otherwise commenced e.g. by an eMCCD) triggers a Level 2 review | |
| 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 randomised and the review is either underway or has been completed, the registrar will provide the information 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 scanned and 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 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, and the registrar will inform the outcome of the review to the informant as well as 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 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[5] In brief, the medical reviewer and the certifying doctor will explore options including amending (by means of a signed and dated note/email attached to the original MCCD, or an annotated and initialled MCCD) or replacing the original MCCD. This will either lead to the amended or replaced MCCD being considered now to be 'in order' (see Step 5) and registration able to conclude, or 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.[6] In brief, the senior medical reviewer may re-review the case again with the certifying doctor and if there is still no agreement, may decide the review is completed (see Step 5). 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. 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. |
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 to the Procurator Fiscal (PF) if criminality is suspected as specified in the Act.[7]
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 cannot be conducted where the death pre-dates the implementation of the 2011 Act; must be requested within three years of the date of death; can only be conducted if a review has not already taken place; and cannot be conducted where the case has already been reviewed by the Procurator Fiscal.[8]
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 the Registrars. As such, the duty to inform the Registrar General of any such review lies with the medical reviewers.
2.6.3 Interested Person review request is a request for the review of 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 have been specifically requested they should be conducted as Level 2 reviews. If the medical reviewer considers that an application for an interested person review is vexatious, they have the power to reject such a request.
2.6.5 Section 4 of the 2011 Act includes a definition of who is an 'interested person'. Scottish Ministers have made no further provisions in respect of naming any other parties therefore this list should be regarded as definitive until further notice.
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 this means the definition of interested person; that the death did not occur more than three years previously; that it does not pre-date the implementation of the 2011 Act (13 May 2015) and that a review has not already been conducted. 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, the request is refused and the DCRS records the outcome of the request and provides a response to the applicant. This may include advice to pursue the enquiry about 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 where Scottish Ministers have not suspended the system in the event of e.g. a serious epidemic. Where such a suspension has been made, all randomised selection of cases will stop and reviews already underway will halt and the registration will be completed.[9]
2.7.2 Any interested person review requests should be logged and should receive a standard reply explaining that provisions have been suspended and will be considered only once such suspension has been lifted.
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. It is therefore anticipated that the new 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), sections 6 and 7 of the 2011 Act provide powers to enable an 'expedited' review procedure, or for the review not to stay registration.[10] 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'.[11]
Key Principles
2.8.5 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 stay registration of death should be available in specific circumstances where there is a clear rationale for a funeral to proceed within a quicker timescale.
2.8.6 In practice, at the point of registration, whether in hours or out of hours, and once an MCCD has been selected for review, it will be a matter for the informant to request that the registration not be stayed, if they have any concerns that the review will have an adverse impact due to a delay in the funeral. The registrar will have responsibility to make the informant aware that the procedure not to stay registration exists, but will not be expected to promote the procedure.
2.8.7 If the informant wishes to request that registration is not stayed, they will make the request to the registrar and must complete an advance registration application form. Section 6 of the 2011 Act requires inclusion in the application to the medical reviewer a statement by the informant which they believe justifies registering the death as soon as possible, and before the review is complete (not staying registration). This statement should be made by way of the advance registration application form (see Annex B).
2.8.8 Once a request has been made it is for the medical reviewer to make a decision as to whether or not to allow registration to continue before the review is completed, based on the information available in the form, from the MCCD and from any other sources he/she considers appropriate.
2.8.9 The registrar must pass on any request they receive to the medical reviewer, and, as set down in legislation, it is for the medical reviewer alone to determine whether the circumstances justify registering the death before the review is complete and whether there are any obvious indications that the MCCD is not 'in order'.
2.8.10 Section 7 of the 2011 Act allows the medical reviewer to require further information and allows them to make any enquiries they consider appropriate. It is expected that the decision as to whether or not to stay registration should be made within 2 hours of the request. In effect, this might share some of the characteristics of a Level 1 review, but would be undertaken before any other reviews planned for that day.
2.8.11 If the medical reviewer agrees to allow the registration to proceed before the review is complete, this will mean that that the registrar will complete the registration and issue the Certificate of Registration of Death (Form 14). The body can be then 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 an autopsy, may not be possible.
Criteria
2.8.12 The Request to Not Stay Registration form (advance registration application form) should be used by informants requesting that registration not be stayed. The form sets out three categories of circumstances where not staying registration might be appropriate:
i. Not staying 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 staying 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 staying 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.
2.8.13 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 stay registration.
2.8.14 It is expected that not staying 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.
2.8.15 The above principles can be summarised in the following process:
| NOT STAYING REGISTRATION (ADVANCE REGISTRATION) (Process 4) | |
|---|---|
| Death occurs | |
| Step 1 | MCCD is completed by certifying Doctor |
| Step 2 | Informant takes MCCD to register death with Registrar |
| Step 3 | MCCD is randomly selected for a Level 1 or Level 2 Review |
| Step 4 | 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 randomised and the review completed, the registrar will provide the information about the review and its outcome. |
| Step 5 | The Informant requests the registration is not stayed 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. Registrar provides a copy of Request to Not Stay Registration Form (advance registration application form) to be completed by the informant. (In normal circumstances the form will be completed while in the registrars' office.) |
| Step 6 | Registrar will contact the DCRS immediately to alert them to the request, and will provide electronic copies of the form and MCCD. Registrars must pass on any requests for registration not to be stayed. |
| Step 7 | DCRS records receipt of the MCCD and the request to not stay registration (advance registration application). |
| Step 8 | Medical reviewer will consider the MCCD and the Request Form and will make a decision as to whether or not registration should be stayed. The decision will be based on
|
| Step 9a | If not staying 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 request 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.
|
| Step 9b | If not staying 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) |
2.8.16 There is no appeal of the medical reviewers' decision following consideration of a request to not stay registration.
2.8.17 All requests to not stay registration - whether granted or not granted - will be peer reviewed regularly to ensure consistency and quality.
Contact
Email: Sarah Dillon
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