Clinical Governance is a valuable framework for assessment and improvement of service provision quality with a coherent program [1] . Risk management is one of the 7 pillars of clinical governance (patient and public involvement, education and training, use of information, risk management, clinical effectiveness, clinical audit, staff and staff management) that is not applicable alone [2] . Risk management is identification, assessment, control, and suggesting some interventions to minimize, or eliminate unacceptable risks [3] . It is a set of guidelines, protocol, steps, organizational and clinical procedures to decline hazardous and unexpected events for patients [4] . Improving the quality of clinical care provides an opportunity for safeguard clinical practice beside staff ability for high quality care [5] .

Obstetrics beside aviation, nuclear power plants, military and chemical manufacturing were categorized as high hazardous industries. It shows the complexity of this field with a cascade of events leading to severe accidents. Obstetrics risk management is a paramount tool in preventing or reducing the adverse events for both patients and staffs. Although during recent years just a few percentage (0.7% - 0.9%) of obstetric patients need to be admitted in ICUs, incidence of severe maternal morbidity is rising [6] . In United Kingdom, 10.8% of obstetric cases faced a complicated situation in which one third of them will end in moderate-severe morbidities or even to death. It is estimated that, at least half of these poor prognostic events could be prevented [7] .

Since early 20th century, many risk management strategies were applied to prevent and decrease maternal and neonatal mortality and morbidity [8] . The aim of risk management is improving quality of health care services and creating a safer system of care [9] . Recognition of risk: its potential, frequency and severity is the first step and its elimination is in the second place [10] . All health care staffs including physicians should be aware of the risk management principles. It is a tool to decrease both hazards and litigation [9] . Consequently by improving healthcare quality and safety, Risk Management will reduce financial burden in health care system [4] .

This is one of the few studies in obstetric risk management in Iran. Our study attempts to identify fetomaternal risks in labour wards of 5 different hospitals (private, public and teaching public) in Tehran-Iran. In this article, we offer some practical risk management strategies to decrease obstetrical adverse events remarkably and provide better pregnancy outcome.

This descriptive, cross sectional study was carried out in 5 different hospitals (Milad, Mostafa Khomeini, ValiAsr, Khatamolanbia and Akbar abadi) in 2011-2012. We incorporated different types of hospitals (public, private, teaching). We organized a secretariat for this project including: 12 Obstetricians/perinatalogists and midwives who were in charge of Maternity Units in these hospitals. A 2 days’ workshop was held for them to get familiar with principles of Clinical governance including Risk Management. Then we asked each group of delegates from these hospitals to report the most prevalent complications and common errors in their labour and delivery-post partum ward, including maternal and neonatal life threatening events, and medico legal complaints. Reported complicated events are shown in Table 1.

In the next step we asked the participants to allocate scores 1 to 10 for each of the mentioned complication with respect to below mentioned indices:

1) Probability of complication occurrence;

2) Possibility of prevention;

3) Priority of interventions;

4) Possibility of getting favourable result in the short time with the least interventions.

Finally the expert panel including 14 members of the Obstetrics & Gynecologists (4 members), Perinatalogists (3 members), Midwives (6 members) and Neonatalogist (1 member) cooperated in evaluation and analysis of the results related to common errors and their causes. The expert group based on the results, concluded that post partum haemorrhage, labor management problems, and neonatal hypothermia were the most prevalent

complications. Then based on Risk Management Rules in Clinical Governance, the complications analysis was done with use of failure mode and effects analysis:

1) We examine the process in all these complications.

2) Identify the “failure modes”.

3) Establish the consequences (effects) of each failure mode.

4) Identify contributory factors.

5) Determine the Weight of contributory factors and/or failure mode regarding its frequency or possibility of occurrence.

6) Identify factors that could prevent, detect, monitor or mitigate this risk).

7) Prioritizing the risks.

8) Design an action Plan.

The results were that the main pitfall of most of these complications arise from poor screening and recognition of high risk patients as well as deficient policies in service provision in all these 5 hospitals (Table 2), and deducted that addressing common infrastructural problems, will help us in designating the plan of management.

After some interviews and discussion with the experts, we proposed some basic changes for better service provision.

Our study was approved by the ethic committee of Tehran University Medical of Sciences on 2011.10.29 (ID: 90-04-159-17420).

We found that the most prevalent complications in these hospitals were post partum haemorrhage, labor management problems, and neonatal hypothermia. We also observed that these risks were similar and their main problems were due to deficiencies in infrastructures. We categorized all main infrastructural problems/man- agement in two divisions: Outpatient and in patients and then determined how some factors can affect risks, Table 3, Table 4.

In inpatient-outpatient risk management approach, we use the comprehensive patient safety strategy on obstetrics events. We analyzed the contributory factors based on five items including organization and management, human factors, environmental factors, technology factors and maternal related factors Table 5, Table 6.

Based on finding common infrastructural problems were defects in Risk Assessment and Hospital Management Policies. We focused on basic infrastructural management in these 2 main subjects. Our main problems in these two fields were related to staff management and hospital management issues.

Maternal mortality rate (MMR) in Iran has declined from 120 in 1990 to 21 in 2010 (comparable with developed countries) and we are going to maintain our achievements in Maternal Health. Iran is the 7^th successful country that has fulfilled the Millennium Development goal with 81% reduction in MMR [11] .

Despite this triumph, direct causes like postpartum hemorrhage (27%) and preeclampsia (13%) are still the major causes of maternal death in Iran [12] . Using the principles of risk management could be an essential approach in reducing complications.

The main strengths of this study were incorporation of different type’s hospitals (public, private, teaching). So

this strategic planning can be implemented in our different hospitals and even in other developing countries with the same pattern of maternal risks, as well.

Our accumulated data gathering from 5 hospitals showed that the post partum haemorrhage, labor management problems, and neonatal hypothermia were the most prevalent complications. Others studies also showed these high prevalence complications: Almeida et al. reported of 1764 neonates, Hypothermia 5 minutes after birth and at NICU admission was 44% and 51%, respectively [13] . Cheng et al. also pointed to 25% of maternal deaths attributed to postpartum haemorrhage (PPH) in developing countries [14] . Duncan et al. demonstrated that poor progress is the most common reason given for medical intervention in labour and failure to recognize the variety of underlying causes leads to suboptimal care [15] .

We saw that our main pitfalls are not related to technologic deficiencies but dramatically associated with managerial and organizational deficiencies. Problems related to human factors were at the second level and environmental, social and technologic bond problems were at the end of the list. Our results were consistent to other studies: Verbano in 2004 has rendered a risk categorization related staff and hospital management issues [4] . Cottee et al. also confirmed that Risk management strategies should cover branches related policy making, guideline, human factor (and it’s relation with tool and environment), environmental and financial aspect, technology and equipments, audit and education [3] [9] . Sultan et al. reported that in critical care services, providing labour-ward staff with adequate knowledge, practical skills and infrastructure is necessary [16] .

Since we have mainly managerial and staff dependent problems (affecting maternal health which are amendable with a comprehensive program with clinical governance approach) we suggest a pathway for improvement of these two.

Step 1. Organization and management

Focus on managerial factors in 3 categories:

・ Training;

・ Provision of appropriate referral system;

・ Provision of follow up system.

Training:

In obstetrics we are not able to predict all emergency condition. People who involve cares for pregnant mothers have to be aware and be trained for responding to emergencies [17] . In the United Kingdom more than 90% of OB ward staffs have been trained annually [9] . Different Types of errors (intended and unintended) may occur in recognition, attention, memory and selection during working hours. Some error may happen due to mistake or violation [7] . Studies have shown that training and education decrease the risk of error to one quarter [10] . So we think that:

・ It is a must for every personnel working in prenatal clinic or labour ward to have adequate competencies which should be provided by Training Courses.

・ Arranging appropriate training courses (verbal and practical training), pre service and in service. During Which gaining acceptable grade is obligatory for passing the course.

・ For personnel’s error: a system provision of training courses should be provided.

・ Simulation/drill courses for rare but fatal complications such as eclampsia would be efficient. There are some rare situations that staffs may not have faced before, like shoulder dystocia, vaginal breech delivery, cord prolaps. These simulation courses would be beneficial [7] .

・ Provision of training file for each staff to record their activities and their grades which should affect their annual promotion.

Provision of appropriate referral system:

Timely recognition of the risks and Referral Of obstetric Patients can play a life saving role in emergency treatments and has crucial effects on the pregnancy outcome. [18] . Predicting which pregnant mother will experience high risk condition is difficult, so for all pregnant women there should be an efficient risk screening and referral system. Referring mothers at the onset of life-threatening complications has a great value and increases the use of available hospital services [19] . In order to recognize high risk pregnancy sooner and on time referral, we suggest:

・ Every pregnant woman should have a file (either electronic or Hard Copy) which shows her health status. It should be presentable wherever she goes (In this comprehensive file, there should be a description of all health data including her risk factors and chronic diseases if any).

・ There should be an alertness about the possibility of transformation of Low risk Pregnancies to High Risk cases, so a complete history taking and risk assessment should be a Must in this regard.

・ The access to electronic file or hard copy should be possible 24/7, so nothing would be missed whenever the patient comes to the same emergency unit.

・ At the same time the patient should have a summary of her health status as a hard copy, so that if she goes to anywhere else, she will be cared in the best way.

・ In crowded clinics, the patients should be triaged based on their risk factors, and there should be time scheduling, to prevent over crowdedness especially for high risk pregnancies.

For determining the exact method of Management in High Risk Patients:

1) Upon recognition of the High Risk Patients, She should be referred to higher level of care for determining the best plan of management for the following remaining months of her pregnancy, with special attention to the best place for her prenatal care programs and delivery (Both should be determined in the referral report.).

2) Once the high risk patient has been recognized, she should be targeted for follow up program up to the end of Post partum Period.

3) These program includes those mothers with sudden changes from Low risk ones to high risk population as well.

4) Provision of outreach programs.

Provision of Follow up System:

Previous reports confirmed some problems in evaluation of risk presented by women due to inadequate follow-up during the pre and postpartum period. Arulkumaran in his study indicated that in England (2007) about 89% women were satisfied with care in labour and birth but this satisfaction in post natal period had not been justified [5] [20] . We speculated that some measures could be beneficial:

・ A system should be foreseen for follow up, in which high risk patient either during prenatal care or postpartum period will be followed. Nothing should be missed even based on the infrastructure: a follow up software can help.

・ This follow up system should include antenatal breastfeeding and child birth preparation training course and problem solving session in the postpartum as well as looking for high risk mothers’ welfare.

・ In this system which should be linked to the Hospital official jobs a group of midwives will be in charge, for training courses and in each shift, but in the case of high risk recognition and reporting, every midwife in shift should report the above mentioned patients for targeting and follow up from that time, which necessitates the presence of a good registry system in the hospital.

・ There should be cooperation outside the hospital with the health centres for further follow up.

・ There should be an alert system in this follow up system.

・ For referral Patients, a detailed feedback report should be provided.

Step 2. Human Factors

Failure to monitor, observe, or act, delay in diagnosis, incorrect risk assessment, inadequate handover, no attention to out of order equipment, no preoperative checks, not following protocol, not seeking necessary helps, failure to manage adequately a junior member of staff, incorrect applied protocol, treatment given to incorrect body site and wrong treatment given, all of them are reported as human factors in risk management [21] however, human factors are partly related to managerial system and partly are individual dependent so these 2 should be approached as follows:

Managerial problems which should be corrected:

・ Lack of Guidelines and Protocols which makes correct management difficult.

・ Lack of uniform policy in managing the patients.

・ Poor attention to eligibility criteria in job description.

・ Lack of policies to determine competencies before starting the Job and inadequate supervision programs.

For reversing the process, there should be a strong willingness to:

・ foresee the necessary guidelines and protocols to make a uniform plan of management and using competent professional personnel’s to take charge with adequate Audit and Feedback.

Personal Problems which as well are a mirror effect of poor managerial policies should be solved in these ways:

・ Active participation in training courses is a must.

・ Jobs should be allocated based on profession.

・ In each departments expert people should be involved, and in the absence of the main person, someone with the same profession and competencies (familiar with the system) should be replaced even in the short term.

・ Rotational working or staff turnover is not beneficial, neither for the system nor for the patients. It should be prevented.

・ If an error (after auditing the problem) has indicated human factors, the involved person or team should be evaluated about their competencies and scheduling necessary training courses. Condition, frequency, degree and causes of error occurrence should be evaluated, too [7] .

・ If a recurrent error from the same person is observed, her/his continuing work in the same job is to be reconsidered.

Least but not the Last is the necessity of active audit and feedback in risk management, which could guarantee system improvement, and for this essential improvement, there should be a multidisciplinary team.

In our obstetric hospitals, most common complications had similar managerial and staff dependent problems. We need to focus on the roots and infrastructural structures then apply pathways for improvement of these two.