Ministry of Health

CLINICAL AUDIT For EFFECTIVE DELIVERY of MATERNAL CARE IN KENYA

Standards for Maternal Care in Kenya December 2002

COLLABORATION OF PROFESSIONAL SOCIETIES OF KENYA AND THE UNITED KINGDOM

Royal College of Obstetricians & Gynaecologists

The Professional Societies of Kenya and the United Kingdom are committed to developing clinical audit for effective delivery of maternal care in Kenya through partnership

Acknowledgment: R.K Kulundu, Dr Otieno and Sr J. for use of cover photograph 9966 9644 3 6 Clinical Audit for Effective Delivery for Maternal Care in Kenya National Joint Steering Committee for Maternal Health Kenya 2003 Coordinators: Kenya Obstetrical and Gynaecological Society PO Box 19459 Nairobi Kenya National Nurses Association of Kenya PO Box 49422 Nairobi Kenya Other collaboration partners in Kenya and UK can be contacted through the above associations Any part of this document may be copied or adapted to meet local needs without prior permission, provided that the parts copied are distributed free. Any commercial reproduction requires prior permission from the National Joint Steering Committee of Kenya and the UK Steering Group who would appreciate receiving a copy of any materials in which portions of the document are used.

CLINICAL AUDIT for EFFECTIVE DELIVERY of MATERNAL CARE IN KENYA

KEY POINTS
1. The audit process will assist in improving performance and effectiveness in clinical practice. Successful implementation of the audit process will help to enhance the quality of maternal care in Kenya. 2. These audit processes are focussed around emergency obstetric care and as in the case of standards, were developed for all levels of heath care provision in Kenya through discussion with a multidisciplinary group of health care providers. 3. It is recommended that Clinical Audit for Effective Delivery of Maternal Care in Kenya be used in conjunction with the companion publication Standards for Maternal Care in Kenya. 4. It is hoped that the use of Standards for Maternal Care in Kenya and this Clinical Audit manual will assist health care providers to contribute to improvements in the delivery of maternal and infant health services.

September 2003

TABLE OF CONTENTS
PREFACE FOREWORD ACKNOWLEDGEMENT EXECUTIVE SUMMARY i ii iii iv v 1 1 2 2 2

LIST OF ABBREVIATIONS AND ACRONYMS CHAPTER 1 BACKGROUND

Introduction. The Standards developed Rationale for the choice of the Standards developed Role of Clinical Audit Manual in implementing the Standards

CHAPTER 2

3 3 4 5 6 6 6 7 8 10 10 11 12 13 16 20 21 23 23 24 25

KENYA QUALITY MODEL Concept of quality and quality improvement in health care Kenya Quality Model Quality improvement in maternal care in Kenya

CHAPTER 3

WHAT IS CLINICAL AUDIT? Definition Types of audit Clinical audit and research Ethical considerations in clinical audit

CHAPTER 4

THE PROCESS OF CLINICAL AUDIT Developing standards Setting up an audit team Step 1: Choosing standards to audit Step 2: Measuring current practice Step 3: Feedback and identification of changes needed Step 4: Implementing changes Step 5: Re-evaluation of practice

CONCLUSION NEXT STEPS APPENDIX

SOURCES AND SUGGESTED USEFUL READING

Examples of audit cycle process from two pilot sites; Kenyatta National Hospital & Sabatia

PREFACE
The Know-How Project was conceived in Kenya in 1998. The purpose of the project is to demonstrate the capacity of professional midwifery, nursing and medical organisations to play a strategic role in the provision of maternal health care through partnerships within and between countries. It was anticipated that the collaborative activities among various health professional bodies will contribute to the project goal which is to improve maternal health in Kenya and globally. Clinical Audit for Effective Delivery of Maternal Care in Kenya, is the companion booklet to the already published standards manual entitled Standards for Maternal Care in Kenya (December 2002). The first step in the clinical audit process is the setting of standards. This is now accomplished. The next step is the process of clinical audit. It is envisaged that clinical audit will be incorporated into the Kenya Quality Model for effective delivery of maternal care in Kenya. The clinical audit process in this document focuses on Emergency Obstetric Care provided by both hospitals and health centres. The process was undertaken and monitored by a multidisciplinary group of participants under the guidance of the Kenya and United Kingdom Steering Groups and Technical Resource Persons. The audit process has five steps: 1. 2. 3. 4. 5. Select standards to audit Measure current practice Feedback and identify changes Implement changes Measurement II

As the reader follows through the five steps, achieving the health delivery objectives through the clinical audit process will become clearer. Apart from improving the quality of health care delivery, it is expected that reduction in maternal and perinatal mortality and morbidity rates will be the outcome of undertaking standard setting and clinical audit. It is anticipated that the process of setting standards and carrying out clinical audit will also ensure that high quality of care will result in improved facility utilization and client satisfaction. Co-ordinators, Kenya Steering Group Dr. Joseph Karanja Mrs. Evelyn Mutio Technical Resource Persons Dr. Edwin Were Mrs. Shehnavaz S. Talib Dr. Nynke van den Broek Mrs. Gillian Barber This manual was collated by: Dr. E. Were (KOGS) Mrs. S. Talib (NNAK) Ms. G. Barber (RCM and RCN) Ms. C. Warren (Population Council) Mr. W. Liambila (Population Council) Dr. N. Broek (RCOG)

FOREWORD
The finalization of the Clinical Audit for Effective Delivery of Maternal Care in Kenya document marks yet another important milestone in the development of not only the Kenya Quality Model but also the entire health care delivery system. Readers of this manual will recall that in a space of eight months, the Safe Motherhood Know-How Project, with support from DFID, has been able to finalise two important but related documents in the area of obstetric care. The other document is Standards for Maternal Care in Kenya 2002. This remarkable achievement is a clear testimony that the partnership between the Ministry of Health and the Health Professional Associations of Kenya and United Kingdom to improve quality of maternal care has been indeed focused and results oriented. On behalf of the Department of Standards and Regulatory Services, I thank DFID for having provided financial resources, which have enabled this partnership to develop the two documents. An important relationship exists between the Standards for Maternal Care in Kenya 2002 document and the Clinical Audit for Effective Delivery of Maternal Care in Kenya manual. The former is concerned with the issues of identifying problems or areas that require improvement and agreeing on what should be done. On the other hand, the latter focuses on how to carry out the identified activities or processes. May I emphasise the fact that clinical audit is based on the management principles of total quality management (TQM) and continuous quality improvement (CQI). It is our expectation that the experience gained through the Safe Motherhood Know-How Project will benefit many health workers at all levels of the health care delivery system in Kenya and that the spill over effect will cut across other medical disciplines. It is our long-term goal to have in place evidence based standards and guidelines in all aspects of health care delivery. I congratulate all the contributors and all those who directly or indirectly contributed to the development of this manual.

DR. TOM MBOYA OKEYO, MBchB MPH HEAD, DEPARTMENT OF STANDARDS AND REGULATORY SERVICES; MINISTRY OF HEALTH, KENYA September 2003

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ACKNOWLEDGEMENTS
This manual is a follow-up to the Standards for Maternal Care published under the auspices of the Safe Motherhood Know How Project; December 2002. Members of various professional associations in Kenya and the UK developed the manual. The professional collaboration between the National Joint Steering Committee (NJSC) of Kenya and their counterparts, the UK steering group are specially acknowledged for combining effort to develop a document that addresses a felt need in health care delivery. In the United Kingdom, John Snow International (UK), and the UK Steering Group, consisting of members of the RCOG, the RCM and the RCN provided exceptional professional assistance. Similarly, the Kenyan team consisting of various professional associations are acknowledged for having made an important contribution through the provision of office space, time and other resources. The Ministry of Health has been an integral part of the whole process. In particular this process of setting standards and piloting the audit cycle would not have been possible without the Department of Standards and Regulatory Services and the Division of Reproductive Health. This process of stetting standards & piloting the audit cycle would also not have been possible without the Department for International Development (DFID) UK. DFIDUK is acknowledged for supporting the development of both the Standards for Maternal Care in Kenya and Clinical Audit for Effective Delivery of Maternal Care in Kenya. Technical support offered by Population Council has also contributed towards making the Safe Motherhood Know-How Project a success. To professional colleagues in the UK and Kenya who encouraged and supported the Safe Motherhood Know-How Project in so many different ways Asante Sana* * (Swahili for: Thank-you very much).

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EXECUTIVE SUMMARY
In the Standards for Maternal Care in Kenya manual the background to the Safe Motherhood KnowHow Project and its outcomes have been fully discussed. This companion manual, Clinical Audit for Effective Delivery of Maternal Care in Kenya is instructional in how-to carry out a clinical audit. The Ministry of Health has for a long time, identified that Evidence Based Practice (EBP) and Continuing Medical Education are essential for health care providers. To facilitate and update basic training knowledge and skills, the MOH has endorsed the development of this document in line with the Kenya Quality Model. The collaborative structure between the MOH and health professionals in Kenya and the UK has strengthened and culminated in the publication of this manual. This collaborative project between the MOH and multidisciplinary group of professionals from Kenya and the UK has exceeded expectations in terms of success. The collaborative effort has already crossed into the realm of regional interest and cooperation. Clinical audit is the systematic review of the quality of clinical care based on standards of care agreed upon by all the relevant health care providers. The standards spell out the ideal and locally relevant care based on currently available evidence on the subject. The standards, further, specify the minimum structure (manpower, equipment, supplies and physical space), the processes and the expected outcome relevant to the standards. In the companion booklet on Standards for Maternal Care in Kenya, thirtyone standards are provided. Clinical audit is commonly an intra-institution exercise. It is based on the management principles of total quality management (TQM) and continuous quality improvement (CQI). One of the aims of the Safe Motherhood Know-How Project was improving the competency of health care providers in the delivery of essential maternal care. We hope this document will contribute to this aim and have impact on service delivery and in reducing maternal mortality rates.

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LIST OF ABBREVIATIONS AND ACRONYMS

Note: Abbreviations & Acronyms already defined in Standards for Maternal Care in Kenya are not repeated in this Manual.

cf DFIDUK e.g. i.e. JSI-UK KMOH KQM NJSC TBA TQM

compare Department for International Development United Kingdom for example that is John Snow International, United Kingdom Ministry of Health, Kenya. Kenya Quality Model National Joint Steering Committee Traditional Birth Attendant Total Quality Model

CHAPTER 1
Background
Introduction
The idea of the KnowHow Project was conceived in 1998. The core mission of the project was to contribute to improvement in maternity care in Kenya through the fostering of a broad based collaboration involving all professional associations that have a stake in maternal health. Through such collaboration, the professional associations would demonstrate leadership in enhancing and sustaining the quality of maternity care within the country. Apart from inter-professional collaboration, the project was intended to foster international collaboration between the Kenyan and UK professional associations. The rationale for this North South collaboration was that the UK associations had had longer experience with the process of standards setting and audit; and offered potentially useful lessons for their Kenyan counterparts. Arising out of this, the following professional associations and organizations came together: Kenya Obstetrical & Gynaecological Society National Nurses Association of Kenya (& Midwifery Chapter) Ministry of Health, Division of Reproductive Health and Division of Nursing Nursing Council of Kenya Royal College of Midwives Royal College of Nursing Royal College of Obstetricians and Gynaecologists The associations agreed on four initial themes on which they would jointly work with a view to improving quality of Maternal Health in Kenya. These themes were: Standards Audit Training and Advocacy
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These themes were in line with the Kenya Reproductive Health Strategy 1997-2010 and the Department for International Development (DFID) priorities for maternal health. This paved the way towards gaining political commitment to the project by the Ministry of Health, Government of Kenya and to financial support for the project by DFID UK. Subsequently, the Ministry of Health, the Government of Kenya, was involved in the process through the Department of Standards and Regulatory Services and the Division of Reproductive Health. In the ensuing interactions a National Joint Committee (NJC) consisting of representation from the participating Kenyan Professional Associations, namely: KOGS and NNAK, was formed to steer the activities of the Know-How Project. In February 2000, UK partners and DFID agreed on standard setting and audit cycle as the themes for the Know-How Project. Subsequently, the core collaborators: KOGS, NNAK and JSIUK agreed on a plan of action and a project memorandum was submitted to DFID. The NJC on Maternity Care was renamed National Joint Steering Committee (NJSC) with two joint coordinators. At this stage the NJSC was expanded to include: Division of Reproductive Health Division of Nursing Nursing Council of Kenya Clinical Officers Council of Kenya Population Council Kenya Clinical Officers Association Kenya Medical Womens Association Private Midwives Association

Having set up the collaboration structure the main objectives of the Know-How Project as per Memorandum were: 1. Development of national standards for maternal care

2. Pilot of model audit cycle 3. Getting the KMOH to adopt the standards and audit cycle.

The Standards developed

Standards of care were developed through a series of participatory meetings and workshops, between November 2001 and March 2002, iniiinvolving members of the various professional assassociations and facilitated by two Kenyan and two UK consultants. The project decided to develop standards on emergency obstetrics and also general standards that covered the rights of women including dignity. Each standard developed consisted of an objective and structure, process and outcome criteria relevant to the standard. An effort was made to make the standards conform to the characteristics of: specific, measurable, achievable, relevant and time-bound (SMART). The standards were also based on available scientific evidence. These standards are now available in print: Standards for Maternal Care in Kenya, December 2002.

Role of the Clinical Audit Manual

This Clinical Audit Manual is a documentation of the experiences with the process that has been adopted in pilot testing clinical audit in diverse clinical settings in Kenya. It describes, in a simple manner, a step-by-step approach to developing standards and explains how health care providers can use the standards to audit clinical practice in a systematic and objective way . The manual should facilitate the institutionalization of the process of clinical audit as a tool for enhancing the quality of health services. This would be in line with objectives of the Kenya Quality Model, which is outlined in the next chapter. Complimentary to this manual is the Audit Report, which documents the experiences and results of the process of clinical audit of selected standards in diverse clinical settings in Kenya.

Rationale for the choice of the Standards developed

Emergency obstetrics was chosen as an area where improvement in the quality of service could result in a significant impact on maternal care. This was due to the high maternal mortality ratios in the country reported by the MOH as being in the region of 590 per 100,000 live births1. Using the Three Delays Model2, we recognized that a significant proportion (>50%) of avoidable factors that contribute to maternal deaths are found at the health facility level (the third delay). The first delay due to lack of awareness of danger signs, was also considered modifiable.

1 2

Kenya Demographic and Health Survey, 1998. Thaddeus & Maine 1994 2

CHAPTER 2
The Kenya Quality Model
The Concept of Quality and Quality Improvement in Healthcare
Quality is the degree to which actual performance corresponds to set standards. Deficiencies in quality can be identified in almost all health care settings. This can be private or public, urban or rural, referral or a basic health facility. Deficient quality reduces the benefit to patients or clients. Moreover, it frustrates healthcare workers and often contributes to wastage of scarce health resources. Regular monitoring of the quality of health care and implementation of programs for continuous improvement of quality of health services is therefore a crucial component of an efficient, effective and dynamic health care system.2 The starting point for assessing quality is having set standards of care. These need to be based on the best available evidence; hence the term evidence based medicine (EBM). Even more important is that these standards be locally relevant and feasible. SMART standards are specific, measurable, achievable, relevant and time-bound. Such a set of standards of care is now available as Standards for Maternal Care in Kenya (MOH Dec 2002). These can be adopted or/and expanded for use by individual institutions. Next, it is important to recognize that health services are produced as the eventual outcome of the functions of several interrelated units. Quality deficiency in one unit affects the output of the next and so on. When considering quality of health care, therefore, it is critical to consider the various stakeholders in the eventual production of health service. For example, in essential obstetric care services in a health centre, the clinical staff consisting of the clinical officer and the nursing and midwifery staff provide the actual services. However, the supplies department and the support staff providing the consumables, sanitation, catering, security etc are part of the totality of the
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health service that the client or patient receives. Deficient quality in any one of these areas will negatively impact on the clinical care given to the client. A systems approach to health services allows one to consider broadly all these contributors to the production of health service. This approach involves the chain of activities in each unit. Thus, due to the interdependence of the various units in production of health services, the assurance of quality health services is not the concern of the health care provider alone but that of everyone working in the facility. Engaging the participation of a wider group in issues of health service quality improvement in a facility has the following advantages: People working in a specific area are better placed to identify reasons for poor quality and suggest feasible remedies; The workers are more likely to implement changes that they have participated in developing; Teamwork is enhanced; Ownership is improved; There is a sense of being able to influence the system and; Morale is boosted. As in any service organization, the needs, desires and convenience of the consumers, clients, or patients are the most important consideration in planning and designing health services. The services must, therefore, take local cultural sensitivities into account. Patient and community partnerships are obviously needed in the design and provision of the services if the services are to be locally relevant and acceptable. Similarly, such partnerships should be inbuilt into any service quality improvement efforts.

Franco et al 1994 3

The Kenya Quality Model

The Government of Kenya through the Ministry of Health, Department of Standards and Regulatory Services has adopted the principles outlined in the preceding section. In a document entitled Kenya Health Standards and Master Checklist for Health Services and Systems Monitoring and Evaluation, February 2002, the Kenya Quality Model (KQM) is described. The model provides the conceptual framework for Quality Improvement in Health Care in Kenya. It says: The Kenya Quality Model integrates evidencebased medicine (EBM) through wide dissemination of public health and clinical standards and guidelines with total quality management (TQM) and patient partnership (PP). The issue of quality and quality improvement is not addressed as a separate project or set of add-on activities. KQM promotes quality and quality improvement efforts to a built-in and fully integrated health care system. The Kenya Quality Model is designed to integrate two quality improvement approaches: firstly, the Standards approach to ensure delivery of safe and effective health services and secondly, the gradual introduction of quality management to health managers and service providers. The document further explains that the Departments role is to provide leadership in standardization and regulation. The standards and guidelines can be found in The Kenyan Health Standards and various clinical and public health standards and guidelines. These state the expected performance levels in the Kenyan Health System. It recognizes compliance with the standards as the entry point to quality improvement, outlines the monitoring of compliance through selfassessments by providers and external evaluation by the Health Service Inspectors. Additionally, the Department promotes Total Quality Management as a mechanism for ensuring not only the achievement of the standards in a sustainable manner, but also surpassing them where appropriate. Health services are asked to ensure that continuous quality improvement process and regular selfassessment is a permanent agenda point that should be integrated into existing management meetings. Such self-assessments will be verified by the Health Service Inspectors who will also provide any requisite support on the quality improvement process. The document on the Kenya Quality Model sets out specific definitions and guidelines: KQM definition of quality (adapted from International Standards Organization): The totality of features and characteristics of the Kenyan Health System that relates to its ability to satisfy a stated or implied health need. Quality Improvement in Health is a process: To improve adherence to standards and guidelines, To improve structure process outcome of health services by applying quality management principles and tools and To satisfy clients needs in a culturally appropriate way. Quality Management Principles KQM adopted the following quality management principles: Customer orientation [both external and internal (health worker) customer]; Leadership to provide guidance and motivation to quality improvement; Involvement of people of the organization and stakeholders; Systems approach to management; Process orientation; Continuous quality improvement and Factual approach to decision making. The KQM is therefore the blueprint for standardization of provision of quality services in the entire health care system in all settings in Kenya.

Quality Improvement in Maternal Care in Kenya

The Know-How Project and its main outputs such as the Standards for Maternal Care in Kenya and this manual Clinical Audit for Effective Delivery of Maternal Care in Kenya and the Audit Report must be viewed in the context of the broader Kenya Quality Model. To our knowledge, this project represents the first effort to interpret and implement the vision and mission of the Department of Standards and Regulatory Services as elaborated in the Kenya Quality Model. It is our hope that experience that has been gained in the process during the Know-How Project will be used to introduce the development of standards and implementation of the clinical audit process to a wider group of health care providers and facilities in Kenya. We hope that this will become part of the process of continuous quality improvement in the rest of maternity care and reproductive health in general. The process of clinical audit was intentionally pilot tested in diverse clinical settings. These ranged from the premiere National Teaching and Referral Hospital at Kenyatta in Nairobi and in the largest maternity hospital in Eastern Africa at Pumwani, Nairobi to a Health Centre at Sabatia in rural Western Province of Kenya. We hope the lessons learnt in these clinical settings will guide the implementation process as the Ministry of Health adopts and scales up the clinical audit process in the rest of the country. The Clinical Audit Manual also forms a basis for replication of the process by other disciplines. It will enable them to embrace the culture of quality in health services and begin to implement the Ministry of Health policy of continuous quality improvement.

CHAPTER 3
What is Clinical Audit?
Definition
Clinical audit is the systematic review of the quality of clinical care based on standards of care agreed upon by all the relevant health care providers. The standards spell out the ideal and locally relevant care based on currently available evidence on the subject. The standards, furthermore, specify the minimum structure (manpower, equipment, supplies and physical space); the processes and the expected outcomes relevant to the standards. In the companion booklet Standards for Maternal Care in Kenya, thirty-one standards are provided. Clinical audit is commonly an intra-institution exercise. It is based on the management principles of total quality management (TQM) and continuous quality improvement (CQI). In section one, the Kenya Quality Model (KQM), of which clinical audit is an offshoot was described in detail. Clinical audit is an iterative process aimed at improving standards of care to the level of set standards or better through a participatory and systematic self-assessment. Benefits to patients: Improves: Quality of healthcare provided Outcomes of care Access to and timeliness of services The local reputation of the facility Benefits to the health service: Clearly identifies problems or areas of concern: both administrative or clinical Encourages teamwork between health care providers. Makes clinical practice more efficient by ensuring that everything is done in the best way by the person most suited to the task. This reduces both the This method is justifiable where there are no agreed standards of care. It argues that the occurrence of the adverse event cannot have been the result of good quality care. In this form of audit either individual or group of cases are scrutinized. Ideally,
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stress and the workload for the members of the team. Enables members of the team to extend their roles, increasing job satisfaction and morale. Forms the framework for future planning within the practice. Encourages ownership.

Types of Audit
There are many types of audit. Some types of audit are also sometimes called review. Criterion-based audit Criterion-based audit is the review of the quality of care or practice performance based on measurable aspects of that care or performance (i.e. the agreed criteria or standards of care). The professional experts agree before hand about what constitutes good clinical practice and then use this as a benchmark. In evidence-based medicine, the criteria for good clinical practice emanates from the best available evidence5 Clinical audit as described above is criterion-based audit. In the case of the Know-How Project work the criteria were the Standards for Maternal Care in Kenya. Confidential enquiries Also referred to as significant event audit or critical case analysis, confidential enquiries entail the detailed examination of single adverse episodes in the care of patients. It can be one of the most productive and effective forms of audit and is concerned primarily with the reduction of clinical and organizational error. Good examples are maternal and perinatal mortality reviews or audits. These enquiries can be performed at individual institutional level or can be regional or national. everyone involved in the management of the individual cases should be involved in a mutual examination of the procedure surrounding the incident. The aim is to uncover flaws in the process of care and identify avoidable and unavoidable

factors in the case. Avoidable factors are then followed up in a suitable way. The biggest disadvantage is that there is potential for judgmental attitudes leading to a perception of the process being a witch-hunt.

Critical incident or near miss review Efforts are being made to develop new approaches to gauging the quality of maternal care. While confidential enquiries tend to assess end events such as maternal or perinatal death, it

is recognized that these end-points are considerably less common than their precursor morbidities. Near-miss morbidities are non-fatal outcomes of life-threatening morbidities. Haemorrhage, infections, eclampsia and obstructed labour can each be the cause of a womans death. Audit based on near-miss morbidity can conceivably generate more data than that based on mortality. It can however be difficult to decide on a definition of morbidity or a near-miss event. Also what can be considered good quality of care in these instances depends very much on the type of health facility and what services it can or should provide.

Clinical Audit and Research

Clinical Audit in many ways resembles research. Rigor of execution is common to both research and clinical audit. Because audit is similar to research, there has been confusion about whether it is the same thing. Research is about establishing the right thing to do, audit deals with ensuring that it is done right3

Smith 1992
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Box 1 compares and contrasts clinical audit and research. Box 1: Research and Clinical Audit Similarities Clinical Audit Research Both aim at answering specific question relating to quality of care Both require careful planning, questionnaire design, sampling, data collection and data analysis Both can be carried out either prospectively or retrospectively Both activities should be professionally led Ensures correct use of evidence Based on standards A cyclical and ongoing exercise Involves nothing beyond normal clinical management of patients Convenience sample size often used Generates new evidence Based on hypotheses Has a definite finite end May involve experiments on patients Based on a scientifically valid sample size

Differences

Source: Standards for Maternal Care in Kenya

Ethical Considerations in Clinical Audit

Audit involves appraisal of actual against expected performance. Data collection approaches used are not very different from those used in research (see Box 1 on page 7.) Confidential patient records are used and patient and health worker interviews are conducted. Audit therefore presents similar ethical considerations to research. Some of the considerations include: 1. Voluntary participation: all subjects involved in the audit process, whether patients, health workers or administrators should participate voluntarily. They may elect to participate or not participate without any fear of victimization. This assurance must be given explicitly. Even after agreeing to participate, a subject is allowed to abandon participation in the process at any time if they so choose, again without any fear of victimization. 2. Confidentiality: those who elect to participate must also be explicitly assured of the confidentiality of the information they provide whatever the nature of the information given. Efforts must also be made to avoid any possibility of identifying the respondents personally or by name from the data collection forms. 3. Maximization of benefits and minimization of risks: the benefits of carrying out the audit should be explained to potential participants in detail. Often, however, audit is meant to improve the future quality of services and so there may be no direct or immediate individual benefit. Rather, improved services may lead to public good. Although there may be no direct risk involved in participating in clinical audit, it is conceivable that if confidentiality is not observed and / or the principle of voluntary participation

not followed then harm can be occasioned to the participants or respondents. 4. Assurance of service regardless of views expressed: this consideration is similar to the principle of voluntary participation. Whether a potential respondent refuses to participate or not, or when they agree to participate and give unfavourable input, they must be assured of the services for which they came to the facility. Where institutions do have formal ethical committees it is wise to consult members

of the committee prior to information being collected for the purpose of audit. Ethical committees need to understand clearly the need for clinical audit and to support this. There must also be a clear understanding of the differences between audit and research. The accompanying Audit Report describes our experiences with this.

CHAPTER 4
The Process of Clinical Audit
Select standards to audit Measurement II Measure current practice Measurement I

AUDIT CYCLE

Plan and implement changes

Feedback and identify changes

Developing standards
This is the indispensable first step. Without standards of care that are agreed and accepted by all professionals that normally constitute the health care team in any discipline, judgment on the quality of care can only remain subjective. The key issue is that standards development must be an all-inclusive process. The sub-steps involved include to: Identify the clinical topic for which standards will be developed Identify and involve all professional members of the health care team. Identify and review available scientific evidence on the standards of care. Agree as a group on best practice based on the best available evidence. The practice should be locally / culturally appropriate and feasible. Identify: o The outcomes that the ideal practice aims to achieve o The processes required to achieve the stated outcomes and o The structure required to carry out the processes consistently and successfully. Discuss the standards to determine whether they conform to the characteristics:
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o o o o o

S specific M measurable A achievable R relevant T time-bound.

These issues have been discussed in detail in the companion document Standards for Maternal Care in Kenya. In the case of the Know-How Project, 31 standards have been developed on aspects of emergency obstetric care and general care. The process of developing the standards has been described in the document and can be replicated in developing standards in any other area of health care. Clinical audit presupposes that standards have been set and agreed upon. The standards outlined in Standards for Maternal Care in Kenya were developed with a multidisciplinary team of health care providers from Kenya and are appropriate for most health care facilities in Kenya. One or more standards can be selected for clinical audit. Alternatively a group of health care providers may decide to develop different standards that cover other areas of care and then audit them.

Setting up an Audit Team

This is a crucial part of the process of clinical audit. As has been mentioned before, the process is an all-inclusive effort to evaluate the quality of care regularly with a view to continuously improving care. Health care is a service that is produced by a team of workers. Each member of the team has an important role to play in the overall functioning of the whole and thus can contribute to the entire performance of the team. As a result, all technical units or sections of the health team need to be represented in the audit team. Mechanisms for regularly updating the others who are not included in the audit team about the audit activities must also be put in place at the outset. In all this we used team meetings and group discussions. A quality assurance storyboard or storybook, can also be used as a mechanism for continuously updating others and, is described later in this manual. In emergency obstetric care audit activities for example; we suggest the following people need to be part of the audit team: A medical officer, where available A consultant obstetrician, where available An anaesthetist, where available A nurse / midwife A clinical officer, where available A records clerk A laboratory technician An administrator

The team needs to be well versed with the process of clinical audit and the standards to be audited. The team should agree on a chairperson and a secretary. It is important to note that the chairperson need not be the most senior member of the team, but they need to be familiar with the process so as to keep the group on track. All proceedings of an audit team meeting should be recorded, circulated to all team members and confirmed at the next meeting. Once such a team is formed and well briefed about the process, clinical audit process begins. The Audit Report includes a description of the various teams that worked on the five different pilot sites as part of the Know-How Project. The report also describes experiences with this type of teamwork. The audit team needs to function as a coherent group of people with a common goal and where all are seen as equals: a meeting of equals.

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The clinical audit process has five steps:

Step 1: Choosing standards to audit

Select standards to audit Measurement II Measure current practice Measurement I

AUDIT CYCLE
Plan and implement changes

Feedback and identify changes

The audit team selects one or more specific standards to audit. Since there are likely to be many standards to choose from, for example the companion book of standards has 31 standards, the team must outline a rationale for choosing to audit a specific standard. All this needs to be documented by the team secretary. For example the standard: A womans right to dignity is respected was chosen for audit by an audit team in a provincial hospital. Their rationale was that: Women preferred to be delivered by TBAs, supposedly because TBAs respected their dignity. Once a standard has been chosen for audit, this information needs to be passed to the

rest of the workers so that they know what is going on. They also need to be informed of the purpose of the planned activities and reassured that this is not a fault - finding process, but a selfassessment process aimed at continuous improvement of the quality of the health services offered. They should be informed that the process is also aimed at improving their working environment and circumstances so that they can deliver quality services. Their opinions should be solicited. This is a somewhat top-down approach and a good alternative would be to have a general meeting of all staff and a consensus about an area or topic for audit before the audit team starts.

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Step 2: Measuring current practice

Select standards to audit Measurement II Measure current practice Measurement I

AUDIT CYCLE

Plan and implement changes As in the development of standards, measurement of current practice requires careful planning to ensure not only collegial support and a team approach, but also administrative goodwill. Support of other health workers, of diverse but relevant categories is essential to avoid misconceptions of faultfinding or witch-hunting. All relevant sections including records and laboratory need to be included. The critical sub-steps in this step include: Identification of all sections that contribute to patient care relevant to the topic to be audited. Representatives from these sections should be invited to be members of the audit team. The members need not be section heads, but should have sufficient time to commit to the task of audit and ideally should be respected members of the sections. Appraise the relevant administration and obtain relevant permission to use patient data and records and occasionally interview patients. Where the institution has an Ethics Committee, permission may be requested, as there are potential ethical issues even in audit.

Feedback and identify changes Once all the relevant authorizations are acquired, the actual preparations for measurement of current practice can begin. The audit team decides what specific standard to audit. Before choosing the standards to audit, the team members need to make themselves aware of the available standards. They should become familiar with the components of a standard the objective, the structure, process and outcome criteria. In making a choice, a clear rationale for this needs to be outlined. A team may choose to audit a standard on management of pregnancy-induced hypertension. A possible rationale may be that it is a leading cause of maternal and perinatal morbidity and mortality in the unit. Subsequent activities are quite similar to research methodology. The key issues to be considered are: The design of the data collection process The data collection methods Data summarization and analysis These issues are now considered in more detail.

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Design of the Data Collection Tools

Before designing the audit data collection process, determine what will constitute the target population for the audit. The population can be: Health workers Patients at discharge from hospital Patient clinical records Work-days or Specific procedures to be observed. In discussing the design, it is worth noting that there can be two broad types of studies. These are: Quantitative studies which lead to data that can be summarized and averaged out numerically and Qualitative studies which produce data about opinions and are normally not expressed in numbers. Further, regardless of whether the data is qualitative or quantitative, it can be collected on an ongoing basis (prospectively) or by looking at the past experience or records (retrospectively). It is not uncommon, however, for information to be collected using varying combinations of the above. For example, both retrospective and prospective studies may incorporate both quantitative and qualitative data. Examples of quantitative data are: Time to Caesarean delivery from diagnosis of obstructed labour, Length of stay in hospital, Number of observation days when staff wore full uniform, Number of partograms correctly filled etc. Examples of qualitative data: Patient opinion on cleanliness of wards Patient opinion on staff attitude to them Staff opinion on their working conditions.

o o o o

questionnaires - interviewer or interviewee (self) administered key informant interviews focus group discussions client windows (as a strategy for collecting qualitative data on patient opinion)

Patient record reviews o data collection/abstraction forms Direct observations o checklists In collecting such data, it is important to ensure that the conclusions drawn from the data are as representative of the true situation as possible. Issues such as whether the data measures what one intends to measure (with respect to the standard). - also called validity; whether the same conclusions would be found if the measurement was repeated, also called reliability come into consideration. The validity of an audit measure depends on whether the correct method and data collection tools are chosen and used. The reliability of the data depends on three factors, The rigor and care taken in designing the data collection instruments, the diligence with which the tools are applied to collect the data and how carefully the data is summarized and analyzed. The method used to identify the specific data sources from the target population such as the patients, workers to be interviewed or the patient files to be abstracted, or the days when the procedures or the structure are directly observed. This is called sampling. Size of the sample studied.

Data Collection Tools

Having decided on the design of the study, it is necessary to then outline clearly how the data will be collected. Each method requires specified data collection tools or instruments. Examples of data collection methods and relevant tools are listed as follows:

Patient interviews
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Audit is labour intensive. Only a few patients can be interviewed, or only a few files abstracted, or procedures observed only on a few of the workdays. If the total numbers of patient, files or workdays are few, then all can be interviewed, reviewed or directly observed. In practice, however, it is usually necessary to choose only a few or a subset of the whole. The process of choosing the few out of the whole is called sampling. Some of the ways of carrying out sampling are outlined below: 1. Probability Sampling. The probability of each participant being chosen in the sample is known. There are three types of probability sampling: Simple random sampling: toss of coin, drawing lots, using random numbers. Systematic random sampling: the first participant is chosen randomly as above and the subsequent ones are chosen at a fixed interval from the first, for instance, every fifth. The interval is determined by dividing the total population by the sample size desired. For example, if the total number of files to be studied is 400, but the resources available allow the team to study only, say, 80 files, the interval would be 400 divide by 80. Therefore every 5th file would be chosen before or after the randomly identified first file. Stratified random sampling: the total intended sample size is proportionately allocated to the various unique groups (strata), for example, primiparas and multiparas, within the sample. Subsequently, the sub-samples in each stratum are derived through either simple or systematic sampling techniques. 2. Non-probability sampling. The probability of each participant being chosen in the sample is not known and consequently it is not known how representative the sample is of the whole. Convenience sampling: this method is often used in audit due to its simplicity. The audit team decides to choose patients

or workdays for interview or direct observation only when it fits their available time-convenience. Quota sampling: convenience sampling where care is taken to include all the unique subgroups (c.f. stratified random sampling) Purposive sampling: the team decides whom to include in the sample. Commonly used for audit where opinion of varied groups are sampled. Finally, determination of sample size is dependent on specific statistical formulae, which are beyond the scope of this manual. Suffice it to say that technical advice can be obtained on this. However, for routine clinical audit for the purpose of intra-institution quality improvement, the sample size is usually dependent on the resources available to the audit team, most important of which is time. The team agrees on sample size that is achievable. Often, it is prudent to test the data collection tools on 10% of the total sample. This allows finetuning of the data collection tools before the real measurement begins. Data collection can be done by members of the team or even by people who are not members. There is a possibility of conflict of interest especially where the people whose services are being audited are doing the data collection. This must be discussed in the audit team and appropriate measures taken to prevent it happening.

Data Summary and Analysis

In summarization it is important to keep in mind the type of data to be collected. Some data (quantitative) can be averaged, others can only be categorized while qualitative data (opinions) can only be described or reported as given. Even isolated opinions are important. For audit, the general trend of the data compared to the criteria set out in the standards is the crucial issue. Where applicable, simple percentages of cases where the standard criteria were met, suffice.

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Step 3: Feedback and identification of changes needed

Select standards to audit Measurement II Measure current practice Measurement I

AUDIT CYCLE

Plan and implement changes

Feedback and identify changes

The purpose of this step is fourfold Communicate the state of current practice compared to the standard to all workers in the unit Collectively, identify the possible causes of sub-optimal or discrepant performance Collectively, formulate solutions to the causes of the sub-optimal performance

Collectively, prioritize the implementation of possible solutions to the sub-optimal performance.

Each of these will now be considered in some detail.

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Communication of results Having analyzed the data from measurement of current practice, the results should be presented in the simplest way possible. It is useful to remember that the purpose of the measurement is to determine whether the current practice is worse or better than the agreed standard practice, based on specific criteria. Presentation of results should therefore bring out these discrepancies. Possible causes of sub-optimal performance can be related to broad categories such as: Personnel numbers, knowledge, attitudes, practices, morale Clientele literacy, culture, knowledge, attitudes, beliefs, practices Infrastructure physical space, water, power supply Equipment Consumable supplies , Non Compliance with standards criteria? SEE box 2.

Identification discrepancy

of

possible

causes

of

It is important to determine the root cause of discrepancies and not simply the superficial/ apparent or immediate cause. Box 2: Structure, Process and Outcome criteria Structure criteria Appropriately skilled staff Process criteria

Outcome criteria. When a woman arrives at the facility she is attended to by a skilled health care provider

Appropriate staff are employed and deployed Staffs are present in the facility or can be called immediately Directions and signs are clearly displayed All staff in the health facility are aware of the flow system Uniform and ID badges are worn Women are directed to the appropriate unit by receptionist. Fees are collected after the clients condition has stabilized

Accessible facilities Clear directions and signs Ground floor facilities (if possible) Client flow plan

Delays at the health facility are reduced. Long queues become shorter

Uniform and ID badges Informed and alert Receptionist A fair and safe system of fee collection that does not prevent access to care

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Box 3 gives examples of some of the tools for such root cause analysis. The process helps to generate and sort ideas or hypotheses about Box 3: Tools for Root Cause Analysis

possible causes of shortcoming within a process. It does not tell which is the root cause and there may be an inter-play of several causes.

1.

Causes by Categories (Fishbone diagram) Assists the group to think of categories of causes Possible categories often used: o Manpower, methods, materials, measurements & equipments o Clients, workers, supplies, environment & procedures o What how, when, where Other valid categories exist. Once the broad categories of causes are identified, all causes pertaining to each group are listed, through simple brainstorming process.

Adapted from L.M. Franco, J. Newman, G. Murphy and E. Mariani: Achieving Quality through Problem Solving and Process Improvement: Quality Assurance Methodology Refinement Series, Bethesda, MD 1994.

2.

Tree Diagram (the Five Whys) Highlights the chain of causes Starts with the effect and major groups of causes For each cause group ask Why is this happening or what is causing this? For each of this next level of causes also ask, Why is this happening? Repeat until no further explanation can be advanced for each of the causes

A solution is then developed for this possible root cause of the problem.
Adapted from L.M. Franco, J. Newman, G. Murphy and E. Mariani: Achieving Quality through Problem Solving and Process Improvement: Quality Assurance Methodology Refinement Series, Bethesda, MD 1994.

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Identification of Solutions to Problems Team effort remains of paramount importance. The team should suggest all possible solutions. Consensus is used to agree on the final solutions. Box 4: Brainstorming as a tool for generating ideas There are tools for enhancing group participation during this phase of formulation of solutions. An example is Brainstorming which is outlined in Box 4.

Brainstorming Rules: No discussion during brainstorming No judgments or criticism of anothers idea All ideas acceptable Building on other peoples idea is acceptable Quantity of ideas count Process: Write the question or issue to be explored where everyone can see it Ensure everyone is sure about the topic Write down all ideas where they can be read by everyone Clarify and combine similar ideas Agree on ways to judge and reduce the list to a manageable number by: o Voting o Prioritization matrices that state the criteria for choice
Adapted from L.M. Franco, J. Newman, G. Murphy and E. Mariani: Achieving Quality through Problem Solving and Process Improvement: Quality Assurance Methodology Refinement Series, Bethesda, MD 1994.

Prioritization of implementation of the solutions

The stage of formulation of solutions often leads to many ideas. It is necessary to prioritize them in terms of what is feasible locally and with the least resources and least disruption of the current practice. Most of the solutions will require few additional resources.

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Step 4: Implementing changes

Select standards to audit Measurement II Measure current practice Measurement I

AUDIT CYCLE

Plan and implement changes

Feedback and identify changes

To implement the solutions that will have been identified and agreed upon, some changes in current practice will be essential. This step is, therefore, largely about effecting change. It operates on the presupposition that change is often resisted. First, the need for change must be obvious to all likely to be affected by it hereafter termed stakeholders. It is important to analyze the potential impact of the suggested changes on the stakeholders and how the stakeholders can either facilitate or impede the implementation of the changes. Arising out of such an analysis will be a list of actions that will lead to the desired changes when effected successfully,. These actions form the basis for an action plan for implementing the changes. Hence two broad actions are carried out at this stage: A stakeholder analysis Formulation of an action plan

Identify and list all possible stakeholders in the change you want to implement For each stakeholder identify: o Title of stakeholder o Interest / role in the suggested change o How they can facilitate the change o How they can hinder the suggested change o Action to be taken with respect to the stakeholder. The actions identified after this analysis then forms basis of a work plan for effecting change.

Formulation of Action Plan

An action plan includes: Action to be taken Who is responsible for implementing the action When the action should be completed The resources required to complete the action and the source. After all the changes have been effected it is prudent to allow for some time to pass before reevaluating practice.

Stakeholder Analysis
In carrying out a stakeholder analysis, the following steps are taken:

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Step 5: Re-Evaluation of Practice

Select standards to audit Measurement II Measure current practice Measurement I

AUDIT CYCLE
Plan and implement changes

Feedback and identify changes

This is carried out in exactly the same way as for the measurement of the current practice. Any variation in the methods or the data collection tools can render the results incomparable with the previous findings. Two possible decisions can arise from this measurement: The practice is still not up to the standard: identify causes of continued sub-optimal

performance and go through the audit cycle again. The standard practice has been attained. The way forward would then be to: o sustain the level of practice or o make the standard more stringent o choose new standards to audit.

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Keeping the Stakeholders Updated All through the clinical audit process, it is imperative that the rest of the stakeholders in the audit process are kept abreast of the developments and progress. As part of the Know How Projects working practice regular meetings were held at all sites where the audit plans, results and problems were presented and discussed. Feed back from the general staff was encouraged. In this way all Staff could feel informed, involved and encouraged. This can also be done using tools such as a quality assurance (QA) storybook and storyboard. The process of depicting the progress in these two formats is called QA storytelling. Box 5: outlines the process of QA story telling through QA storyboard. It allows interested parties to update themselves at their own pace and convenience.

Box 5: Question/Answer (QA) Storyboard

Storyboards use simple, clear statements & pictures and graphs to: Describe a problem Summarize the analysis process Describe the solution Describe the implementation of the solution Display the results Creating and maintaining a QA storyboard: Reserve a section of wall, or acquire a large poster board (1.5 by 2 metres) Mark off specific areas to display: o Results of measurements of practice o Problem statements o Team members o Work plan during problem analysis & results o Root causes identified o Solutions selected o Solutions implemented o Results Update the storyboard on a regular basis as team works through the audit cycle Ensure the updates are made as concise as possible: pictures, graphs, charts are ideal. A QA storybook is similar but is in book format rather than billboard*
*Adapted from L.M. Franco, J. Newman, G. Murphy and E. Mariani: Achieving Quality through Problem Solving and Process Improvement: Quality Assurance Methodology Refinement Series, Bethesda, MD 1994.

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Conclusion:
As stated previously in both Standards for Maternal Care in Kenya and in this Clinical Audit manual improving womens access to obstetric care in Kenya is constrained by a human resource crisis in the public sector in both the rural and urban environments. The KQM recommends standardization of provision of quality services in the entire health care system. The Know How Project has conformed with KQM by providing these two manuals composed from work done in the pilot sites in Kenya. It is hoped that learning the processes of standard setting and clinical audit will facilitate health care providers in appreciating standards & audit as positive tools for change (See Box 6). Box 6: Clinical Audit.

SUMMARY Among many other areas clinical audit is an activity which can be used for: Improving quality of care (KQM). Enhancing the professional development of those involved. Providing opportunities for teamwork. Application of new knowledge. Enhancing communication skills Instilling knowledge about social, cultural, ethical and psychological aspects of care. Managing financial and human resources. Minimising errors in delivery of care.

Next Steps:
Healthcare providers should undertake standard setting and clinical audit in their workplace to access impact of delivery of better health care services. Used effectively standards and clinical audit could help health care providers to improve their routine work and also to build their management capacities In order to clarify the audit process, two examples from pilot sites, namely Sabatia Health Centre in Vihiga District Western Province of Kenya and Kenyatta National Hospital, Nairobi, are illustrated in the Appendix section of this manual. It is recommended that readers refer to these examples for purposes of clarifying the understanding of the process involved.

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Sources and suggested useful reading

Council for International Organizations of Medical Science, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva: CIOMS in collaboration with WHO, 2002. Franco LM, Newman J, Murphy G and Mariani E, Achieving Quality through Problem Solving and Process Improvement, Quality Assurance Methodology Series, Bethesda, MD, 1994.

Second (1997) edition available online at <www.qaproject.org/pdf/intro.pdf>

Graham W, Wagaarachchi P, Penney G, McCaw-Binns A, Yeboah K, Hall M. Criteria for Clinical Audit of the Quality of Hospital-based Obstetric Care in Developing Countries, Bulletin of the World Health Organization, 78 (5): 614-620, 2000. Ministry of Health, Kenya. Kenya Health Standards and Master Checklist for Health Services and Systems Monitoring and Evaluation (DSRS), February, 2002. Morrell C and Harvey G, The Clinical Audit Handbook, London: Bailliere Tindall, 1999

National Institute for Clinical Excellence, Principles for Best Practice in Clinical Audit, Abingdon: Radcliffe Medical Press, 2002. National Joint Steering Committee for Maternal Health, Kenya, Standards for Maternal Care in Kenya, Nairobi: NJSC, 2002. Smith R. Audit and Research, British Medical Journal, 305: 905-906, 1992. Thaddeus S and Maine S. Too Far to Walk: maternal mortality in context. Social Science and Medicine, 38: 1091-1110, 1994.
Wagaarachchi P, Asare K, Ashley D, Gordon G, Graham W, Hall M, Henneh R, McCaw-Binns A, Penney G, Yeboah Antwi K, Bullough C, Improving the Quality of Obstetric Care in Developing Countries through Criterion-Based Clinical Audit: a Field Guide, Dugald Baird Centre for Research on Womens Health: University of Aberdeen, 2002.

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Appendix 1: Examples of audit cycle process from two pilot sites Kenyatta National Hospital
Kenyatta National Hospital (KNH) is located 5 kilometres from the City Centre, off Ngong Road, in Nairobi. It serves as the national referral, teaching, and research hospital in Kenya. It has a bed capacity of about 2000 out of which 130 beds are for maternity care. These are located on the ground and first floors of the ten-storey tower complex. The catchment area population is drawn from Nairobi Province and its environs, which include Kiambu, Thika, Machakos and Kajiado districts. The total number of deliveries is about 8,000 a year. Apart from the bigger Pumwani Maternity Hospital, Kenyatta National Hospital is the only other public hospital in the city. 23 The majority of patients admitted into the maternity wards are not booked for antenatal care in Kenyatta Hospital itself. AUDIT TEAM An audit team was formed consisting of: 3 obstetricians: Dr M Ndavi, Dr J Karanja, and Dr W Khisa 5 midwives: Mrs A Mwangi, Mr S Gacheru, Mrs M Ojanga, Mr P Njamu, Mrs P Balera (2 from labour ward and 1 each from antenatal clinic, postnatal wards and labour ward theatre). 1 anaesthetist- clinical officer: Mr S Ndolo 1 medical records officer: Mr Mbatha Team Leader: Mrs A Mwangi AUDIT PERIOD: November 2002 to March 2003.

STANDARD SELECTED (one example out of three) STANDARDS SELECTED 1. A woman is given the choice of having a companion during antenatal clinic visit, labour and postnatal clinic visit. (General Standard of Care) RATIONALE Having a companion in labour is associated with improved outcome. Psychological support is beneficial. Physical space is available in KNH to accommodate companions.

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Measurements Conducted
1. A woman is given the choice of having a companion during antenatal clinic visit, labour and postnatal clinic visit. Exit interviews were undertaken using interviewer-administered questionnaires for all women who delivered in KNH. Systematic sampling of every fifth woman was used up to a total of 80 women. Information was obtained at the time of discharge, which was 1 day postpartum for women with a normal vaginal delivery and 5 days postpartum for women who had complications of pregnancy or delivery and/or a caesarean section performed. Information was obtained on number of women who had a companion during ANC visits and labour, opinions on the benefits of a companion during ANC, labour and PNC visits and the source of information about choice of having a companion. An example of the data collection form is found within this Appendix. MEASUREMENT 1 1. A woman is given the choice of having a companion during antenatal clinic visit, labour and postnatal clinic visit. During antenatal clinic visits 27 women had a companion with them (33.8%). During labour this was 19 (23.8%) and during postnatal visits this was 19 (23.8%)

PROBLEMS IDENTIFIED
General Problems: TYPE OF PROBLEM Inadequate input by the participating obstetricians Lack of recognition of the importance of the medical records department at the beginning of the project Delay in seeking and getting clearance from the Ethical and Research Committee of Kenyatta National Hospital Suspicion by health care providers in the maternity units of monetary benefits to members of the audit team Fear of victimization of health care workers resulting from the outcome of audit. Lack of support to members of the audit team by different arms of KNH management: RECOMMENDED CHANGES Full participation by the obstetricians Full recognition and participation of the medical records department Project proposal document with a letter seeking clearance was sent to the Ethical and Research Committee in July 2002. Continuous meetings with health care providers (HCP) in the relevant maternity units have been organized explaining the nature of the project result: there is improved enthusiasm in the project Audit team to create awareness among members of management team.

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Problems specific to Standard: 1. A woman is given the choice of having a companion during antenatal clinic visit, labour and postnatal clinic visit. Space was found to be an issue. At the antenatal clinic there is enough space to have a companion with the client. At the labour ward there are 6 first stage rooms. These are meant to be occupied by a single woman only but and usually there is already more than one woman in each room because of the total number of women seen at the hospital. The second stage or delivery room has two couches per room for the general public and one couch per room for private patients. The postnatal wards are very crowded with 60 to 70 beds per ward and these are open wards. Although companions or relatives are given the possibility to visit outside normal visiting hours it is not possible to visit during the night. Therefore if women deliver at night even though relatives may have no transport to go home they will not be able to stay in the postnatal ward. Staff attitude and cultural background was found to play a role. Husbands or a male companion are not accepted. It is the communitys attitude that giving birth is a womans affair. There is a belief that men could become partially impotent as a result of seeing their wives/partners deliver and a case of 6 months complete impotence was anecdotally described. When a woman is brought to the hospital it is further believed that it is now the hospitals affair what happens. Often the husband or male relatives say they only want to know about the bill. There would be less of a problem with female companions. Staff will not allow any relative in the room with a client/patient/woman at the same time as the member of staff. Midwives had a discussion and this was attributed to fear of litigation. At antenatal clinic women said they would appreciate a companion but often relatives do not want to be a companion and also staff do not want a companion present during their examination of the client. This is mainly voiced by midwives but also by some doctors. In discussions with staff the excuseor reason given is often that there is no seat for the companion.

Changes Implemented General: A total of five half-day in-house workshops were organised for all 120 health care providers involved in maternity care to discuss with then the issues of standard setting and clinical audit. Morbidity and Mortality Meetings were used to explain the Audit Project

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Specific to Standard: Seats were provided for companions at the antenatal clinic A 5-minute talk is given to all women explaining the possibility, the importance and the benefits of having a companion at antenatal education talks which are given daily. At the labour ward a selected person is now allowed entry to the client/patient at any time not only during visiting time, as was previously the case. This is being abused a bit though. Education sessions have been organised for staff to improve personal relationships with clients/patients and in particular to learn not to see companions of clients/patients as intruders. At the postnatal wards relatives of women who have delivered in the last 24 hours are allowed to visit even outside normal visiting hours. This includes husbands and family. If there is a problem at the gate the guard can telephone the labour ward to check that the woman in question is eligible for visitors.

Very sick mothers and women who have had a caesarean section are also allowed a companion outside visiting hours and relatives are then given a note which states they should be allowed to visit. MEASUREMENT 2 During antenatal clinic visits 35 women had a companion (46.7% out of sample size 75 women), during labour 31 women (41.9%, sample size 74 women) and at the postnatal visit 29 women (40.3%, sample size 72 women).

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QUESTIONNAIRE for KNH In-patient Number ANC Age Marital Status Parity Level of Education

1. Did you have a companion during: Antenatal clinic visits? Labour? Yes Yes No No

2. Were you given information on the choice of having a companion during: -? Antenatal clinic visits? Labour? Postnatal clinic visits? Yes Yes Yes No No No

3. Do you think it is (was) beneficial to be accompanied during your: -? Antenatal clinic visits? Labour? Postnatal clinic visits? Yes Yes Yes No No No

4. Was your companion given any information as regards your care?

Yes

No

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Sabatia Health Centre

Sabatia Health Centre is a medium sized health facility in Vihiga District, Western Province on the Eldoret Kisumu Road. Its catchment population is 134,000 people. One Clinical Officer leads the HC, with three Community Health nurses and eleven Enrolled Community Health Nurses. It has an average of 24 new antenatal clients per month and about 20-25 deliveries. AUDIT TEAM G. Amanya L. Songon M Indete C. Esilaba B. Kirwa B. Kinzi AUDIT PERIOD: Clinical officer (Team Leader) Nursing officer Nursing officer Nursing officer Laboratory Technologist Records Officer. January to October 2002.

STANDARDS SELECTED: STANDARD 1. Every woman attending antenatal clinic must have her blood pressure measured, urine tested for protein and the results recorded (Pre- Eclampsia) 2. Every woman delivering in a health facility will be monitored with a partograph (Prolonged Labour) MEASUREMENTS CONDUCTED 1. Every woman attending antenatal clinic must have her blood pressure measured, urine tested for protein and the results recorded A total of 100 antenatal cards were reviewed using a checklist (see appendix). 2. Every woman delivering in a health facility will be monitored with a partograph A total of 100 partographs of women who had previously attended the labour ward at Sabatia were selected from the records department and quantitative data from these were collected retrospectively. (See appendix) (100 partographs reviewed out of a total of 130 in store). Improvement in the management of women in labour was needed. In Sabatia partographs were irregularly used and inaccurately filled. RATIONALE Need to ensure women with signs of preeclampsia are identified

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MEASUREMENT 1 1. Every woman attending antenatal clinic must have her blood pressure measured, urine tested for protein and the results recorded During the first measurement 100 % of cards had a blood pressure measurement recorded and 77% had urinalysis performed and recorded. 2. Every woman delivering in a health facility will be monitored with a partograph Of the 100 partographs 60 % had descent of the head recorded and 62% had cervical dilatation recorded for at least one patient assessment. PROBLEMS IDENTIFIED 1. Every woman attending antenatal clinic must have her blood pressure measured, urine tested for protein and the results recorded A regular supply of urine dipstix was put in place The cost of antenatal profile was reviewed by Health Centre Development Committee

2. Every woman delivering in a health facility will be monitored with a partograph Staff needed to be updated in the use of the partograph Supply of partographs was not continuous

CHANGES IMPLEMENTED 1. Every woman attending antenatal clinic must have her blood pressure measured, urine tested for protein and the results recorded 2. Every woman delivering in a health facility will be monitored with a partograph All staff were re trained in the use of the partograph Continuous supply of partographs was ensured

MEASUREMENT 2 1. Every woman attending antenatal clinic must have her blood pressure measured, urine tested for protein and the results recorded During the second measurement 99% of antenatal records had a blood pressure measurement recorded and 79% had urinalysis recorded.

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