Saint Francis Designated District Hospital is located in Kilombero, one of the rural districts in South-east Tanzania. The district has a total area of 14,018 km2 and a population of 331,167 with an annual population growth rate of 2.6%. The district has only two non-governmental hospitals with comprehensive emergency obstetric care (CEmOC) services both located around 75 km apart in the northern part of the district. Because of the geographical locations of these hospitals patients requiring CEmOC services from the most southern part of the district need to travel up to 200 km to reach the closest hospital (SFDDH). SFDDH has a capacity of 372 beds and provides services to patients not only from Kilombero district but also to those from the neighboring districts, Ulanga, Kilosa and Morogoro rural. The average annual delivery rate was 4987 between 2006 and 2008.
Methods are informed by the principles of operations research. The purpose of using principles of operations research was to apply scientific methods, techniques and tools to problems involving the operations of a health system in Tanzania so as to provide those in control of the system with optimum solutions to problems. The principles applied included (1) formulation of the problem; (2) construction of a model of the audit system; (3) selection of a solution technique; (4) obtaining a solution to the problem; (5) establishing controls over the system; and (6) implementation of the solutions .
Development and validation of audit record form
The audit record form was developed and terms (severe maternal morbidities) were defined. At the time when an audit system for maternal mortality and severe morbidities was introduced in this hospital, there was no internationally accepted standard definition and uniform case-identification criteria for severe maternal morbidity . Factors associated with maternal mortality and morbidities were extracted from literature. A panel of 2 experts (obstetricians) reviewed the form for relevance and clarity. Items regarded as relevant for inclusion by both experts were retained in the form. Inappropriate items were either removed or modified based on discussion. The form was piloted on 48 cases of maternal mortality and severe morbidity from May to September 2008. More revisions were made during this period based on the feedback from the team administered the audit record form and those reviewed the data collected. Data collected during this period was not included in this article. The final version of this form had several sections including: background information, socioeconomic status, antenatal care history, previous obstetric history, intrapartum care and areas of substandard care.
Definition of terms and inclusion Criteria
Inclusion criteria were: all maternal deaths, eclampsia, severe obstructed labour (defined as those presenting with (impending) rupture of uterus, haematuria or obstetric fistula), severe obstetric haemorrhage (defined as patients who received at least one pint of blood or estimated blood loss of more than 1000 ml), severe anaemia (Hb ≤ 6 g/dl), puerperal sepsis, severe complications of abortion (defined as perforation of viscera or haemorrhage necessitating transfusion) or severe sepsis [defined as sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities including oliguria or alteration in mental status]), ruptured ectopic pregnancy and any other obstetric complications which the doctors were convinced to be severe maternal morbidities. All patients fulfilling the inclusion criteria were reviewed and selected cases were audited.
Data collection was done in blocks for 491 days from October 6th 2008 until July 8th 2010 using a semi-structured audit record form. While the forms for maternal mortality were completed on the day of the event, those for severe morbidities were completed on the day of discharge. In both cases (mortality and morbidity) copies of the case files and partograms (whenever applicable) were attached.
All cases were discussed in the first place by the senior obstetrician, intern doctors and the medical students involved in the data collection, to establish the cause of severe morbidity or mortality and the related substandard care. The management of the case was assessed and judged against the national guidelines for management of emergency obstetric conditions. In case of missing information in case files the staff who attended the patient and whenever the patient was still in the ward were asked for clarification. All maternal mortalities and selected severe morbidities were discussed in regular audit meetings. Selection of severe morbidity cases for audit was based on the presence of gross substandard care. In these meetings the audit team critically reviewed cases, established the cause of mortality or severe morbidity, underlying substandard care and developed strategic action plans for future improvement.
In order to reach consensus the facilitator involved as many members of the audit team as possible to give their opinions and suggestions about the case. The input and ideas of all participants were gathered, synthesized and the facilitator tested the panel to see if the listed causes, areas of substandard care and interventions were acceptable to all. Although anonymity was emphasized during audit meetings, feedback was provided later by more senior staff in case of health workers related substandard care in order to improve the future management of patients.
The audit team was formed based on the recommendations of the national guidelines for audit team formation at the district hospital. These constituted the hospital medical director, head of department of obstetrics and gynaecology, nurse in-charge of the maternity block, district nursing officer, district reproductive and child health (RCH) coordinator, obstetricians, representatives from RCH clinic, pharmacy, laboratory and operating theatre, and other health care providers from the maternity blocks. The health care providers in this department included 2 obstetricians, 2 generalist doctors (medical doctors not yet specialized), 2 assistant medical officers, 14 midwives. The district medical officer did not take part although he was supposed to do so by the guidelines.
Evaluation of the auditing process
In addition to the routine evaluation of the auditing process that was carried out during every audit meeting, a summary of findings was discussed to evaluate the audit process including implementation of recommendations at the end of every two months.
Data was extracted from the audit record form and entered into Access database and then transferred to the SPSS software for analysis. The characteristics and substandard care of maternal mortalities and severe morbidities were analyzed and compared within the group. The principal summary measures were case fatality rates (a widely accepted indicator for quality care ), proportions of the causes and substandard care as well as mortality risk ratios (RR). The corresponding 95% confidence intervals (95%CI) were also calculated. Statistical significance of the results was estimated using p-value (with a significance level, 'α', of 0.05) and 95%CI. Ethical clearance for the study was obtained from SFDDH Research and Publication Committee. The permission to conduct this audit was obtained from the district and hospital management. Verbal consent was obtained from all women included in the audit process.