CEMACH

Appendix 1: Method of Enquiry

Naufil Alam

The Confidential Enquiry into Maternal and Child Health (CEMACH) has five regional offices in England and works with partner offices in Wales, Northern Ireland and Scotland. The work is co-ordinated by a Central Office in London. Each of the regional offices has contacts within every Trust that provides maternity care, at the Maternity-Unit level. 

The Enquiry has its own Board with representation from the Royal College of Obstetricians and Gynaecologists (which hosts the Enquiry), Royal College of Midwives, Royal College of Pathologists, Faculty of Public Health, Royal College of Paediatrics and Child Health, and the Royal College of Anaesthetists. Recent additions to the Board include the Royal College of General Practitioners and the Royal College of Psychiatrists. 

From 2003 to 2005, CEMACH was commissioned by the National Institute for Clinical Excellence (NICE) to conduct the Maternal Death Enquiry (MDE) in England and Wales. Since 2005, this commissioning role has been carried out by the National Patient Safety Agency (NPSA). In Northern Ireland CEMACH is commissioned by the Northern Ireland Department of Health, which contributes funds for their participation in the Enquiry. In Scotland, the Scottish Programme for Clinical Effectiveness in Reproductive Health (SPCERH), acting on behalf of NHS Quality Improvement Scotland (NHSQIS) conducts its own Enquiry programme, but cases are forwarded to the Enquiry’s central assessors and included in the triennial Report. 

England and Wales

It is a government requirement that all maternal deaths should be subject to this Confidential Enquiry, and all health professionals have a duty to provide the information required. In participating in the Confidential Enquiry, the professionals concerned are asked for three things:

  1. to provide a full and accurate account of the circumstances leading to the woman’s death, with supporting records.
  2. to reflect on any clinical or other lessons that have been learned, either personally or as part of the wider context.

The responsibility for initiating an enquiry into maternal death lies with the CEMACH Regional Manager (RM). Following a pregnancy-associated-maternal-death, a notification is usually made by one of the health professionals involved in the care of the woman to the relevant CEMACH RM. Cases are also reported by the coroners, Local Supervising Authority Midwifery Officers (LSAMO), and others. Data are also cross validated with data received from the Office for National Statistics (ONS). The data received from ONS are discussed more fully below (see “Verification of ascertainment”).

The enquiry is initiated using a standard data collection form (Maternal Enquiry pro forma; MDR-1) which is completed by obstetricians, anaesthetists, pathologists, general practitioners, midwives and any other professionals that were involved in the care of the woman. Copies of case notes are obtained, where relevant, and in some cases additional written statements are supplied. Each case is then prepared for a two stage review and assessment process, the first occurring at a regional level, and the second occurring at a central level. Following collection of all the relevant information, the records are anonymised and circulated by the CEMACH Regional Manager to Regional Assessors (RA). The obstetric and midwifery assessors review all cases. Anaesthetic assessors review all cases where there was involvement of an anaesthetic or intensive care. Every possible attempt is made to obtain full details of any autopsy and pathological investigations, and these are reviewed by the pathology assessor. The assessors add their comments and opinions regarding the cause or causes of death, before returning the completed form to the relevant Regional Office where core notification data are entered onto a database.

The Director of the Maternal Death Enquiry then reviews all cases and allocates the cases for further assessment as necessary. There are a number of central assessors in different specialities, e.g. cardiac disease, psychiatric illness etc. or clinical practice, e.g. midwifery, general practice etc. The Director will make a decision as to which is the most appropriate central assessor to review each case, although a case may be sent to more than one assessor. The Director then works in collaboration with the central assessors to review all available recorded facts about each case, and assess the factors that may have led to death. All details regarding the death, including the agreed clinical cause of death are recorded in a database.

All data and databases are held in accordance with CEMACH’s information security procedures. This ensures anonymity at different stages of the Enquiry process, guarantees confidentiality, and safeguards any identifiable information for the duration it is held.

After preparation of the Report, and before its publication, all maternal death report forms, related documents and files relating to the period of the Report are destroyed, and all electronic data are irreversibly anonymised.

These processes are summarised in figure 1.

Figure 1; Process of Enquiry 2003 - 2005


Verification of ascertainment

Ascertainment is checked with reference to data supplied by ONS. This data are supplied in two forms:

  1. Direct Notifications; these are deaths of women where “pregnancy” is mentioned anywhere on the ONS death registration. These cases are coded as a maternal death according to the International Classification of Diseases, Injuries and Causes of Death tenth revision (ICD10). This would identify all women where pregnancy may have been a contributing factor to their death.
  2. Linkage Notifications; these are deaths of women where the name of the woman appeared on the registration of a birth in the current or preceding calendar year. This would allow for the identification of women who had died up to 364 days following delivery.

This data is cross-matched with the data that has been directly acquired by CEMACH. Any cases that have been identified by one organisation but not the other would then be established. These outstanding cases are then further investigated to ensure that they are pregnancy-associated-deaths, and that they warrant inclusion in the Enquiry and then an enquiry initiated using the standard data collection form.

Regional assessment

Each CEMACH region has one or more sets of Regional Assessors (RA) depending on requirements. Each set includes an obstetric assessor, midwifery assessor, pathology assessor, an anaesthetic assessor and a perinatal psychiatric assessor. Assessors are appointed for the term of the triennium (about 4 years, allowing for completion of assessment). Nominations for medical assessors are sought from the presidents of the Royal Colleges, and nominations for midwives are sought from the LSAMO.

An RA must be an active clinical practitioner in the National Health Service (NHS), in the relevant speciality. If medical, the Regional Assessor should be at consultant level, or, if a midwife, must be at supervisory level. The Regional Assessor should have knowledge and experience of organisation of care, as well as the respect of his/her peers. It is important that the Regional Assessor is able to realistically commit enough time to assess and return enquiry forms in a timely manner. The position is honorary.

The role of the Regional Assessor is to review the information reported in the MDR-1 form, and any other documents that have been assembled by the CEMACH Regional Manager. The Regional Assessor will then make a short report in the relevant section of the enquiry form. All the information provided to the Regional Assessor is anonymised. This report includes a comment on the case, an evaluation of the clinical management and the resources of the organisation responsible for the care of the woman. The assessor is also asked to make a judgement as to whether the care was substandard and, if so, if this was a contributing factor in the death of the mother.

Central assessment

The Central Assessors review each case thoroughly, taking into account the case history, the results of pathological investigations, and findings of autopsy that may have been conducted. Following this detailed investigation, each case is allotted to a specific chapter in the final report.

This assessment occasionally varies with the underlying cause of death as given on the death certificate, and classified by the Registrars General using the ICD10. This is because a death may be coded for a specific cause-of-death, but the pathogenesis of this condition may have been precipitated by an obstetric event. For example, although a given death may be coded as multiple-organ failure as the terminal event, it could have been precipitated by an obstetric event such as septicaemia from an infected caesarean section. Although each pregnancy-associated-maternal-death reported to this Enquiry is only counted once and assigned to one chapter, it may be referred to in additional chapters. For example, a death assigned to “hypertensive disorder of pregnancy”, in which haemorrhage and anaesthesia also played a part, may be discussed in all three chapters.

Authors

Chapters are initially drafted by individual Central Assessors, and then discussed in detail by the whole panel before the Report is finalised. Other acknowledged professionals who have a particular and expert interest in specific diseases or areas of practice may be asked to review and comment on the recommendations prior to publication.

Statistical analysis and data presentation advice to each author is provided by both an independent statistical advisor, and data analysts at CEMACH.

Confidentiality

After preparation of the Report, and before its publication, all maternal death report forms, related documents and files relating to the period of the Report are destroyed, and all electronic data are irreversibly anonymised.

Denominator data

Denominator data and other relevant statistical data are supplied by organisations such as ONS, the Scotland General Registrar Office (GRO), Northern Ireland Statistical Research Agency (NISRA) and Hospital Episode Statistics (HES).

Northern Ireland

In Northern Ireland the same government requirement applies, in that all maternal deaths should be subject to Confidential Enquiry. During this triennium the responsibility for initiating an enquiry remained with the Director of Public Health (DPH) of the health and social services board in which the woman was resident. Maternal deaths were reported to the relevant DPH, who was responsible for organising completion of the MDR-1 by those involved in the care of the dead woman, and obtaining the autopsy report, where one had been conducted. On completion, the forms were sent to the Medical Coordinator at the Department of Health, Social Sciences, and Public Safety. The Medical Coordinator, acting on behalf of the Chief Medical Officer, anonymised the forms, and then coordinated the input of the pathology, anaesthetic, midwifery and obstetric assessors. A single panel of assessors dealt with all cases. Assessed MDR-1 forms, and other collected documentation, were forwarded to the CEMACH Central Office and submitted to the MDE Director for central assessment, as outlined for England and Wales, and illustrated in figure 1.  All data and databases are held in accordance with CEMACH’s information security procedures as for England and Wales.

Ascertainment is checked with reference to data supplied by the General Registrar’s Office in Northern Ireland.

From 2006 the notification is made directly to the CEMACH Regional Manager, who initiates the enquiry on behalf of the DPH and, in conjunction with CEMACH Unit Co-ordinators and professional staff, arranges for completion of the MDR-1 form. The same process of anonymisation and regional assessment is followed as before.

Scotland

A single panel of assessors covers the whole of Scotland. A single assessor representing each of anaesthetics, pathology, psychiatry and midwifery comments on all cases, and each of three obstetric assessors comments on cases from a defined geographical area. The panel of assessors meets twice a year to assess and classify each case. SPCERH administers the Enquiry on behalf of NHSQIS. SPCERH receives copies of all relevant death certificates from the Scotland General Register Office (GRO), and then the SPCERH Administrator notifies the DPH of the health board of the residence of the woman concerned. The SPCERH Administrator takes responsibility for organising completion of the MDR(UK)-1 by all the professional staff involved in caring for the woman. The completed form, with any additional relevant documents, is passed to the appropriate obstetric assessor. He/she determines whether any further documentation is required before the information is submitted for discussion and classification by the full panel of assessors. In cases where an anaesthetic has been given, an autopsy or a pathological investigation undertaken, or where there were significant psychiatric or midwifery issues, the obstetric assessor passes the form to the assessors from relevant disciplines for their further comments. The form is then returned to the SPCERH medical director, who retains it from that time until it has been fully considered, classified and used for preparation of the report. The completed MDR(UK)-1, and addition documentation, is held under conditions of strict confidentiality and is anonymised before being forwarded to the UK Central Office. The cases are then passed to Chapter authors for inclusion in the triennial report.