clinical audit for effective delivery of maternal care in kenya
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Ministry of Health
CLINICAL AUDIT
For
EFFECTIVE DELIVERY ofMATERNAL CARE IN KENYA
Standards for Maternal
Care in Kenya
December 2002
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COLLABORATION OF PROFESSIONAL SOCIETIES
OF KENYA AND THE UNITED KINGDOM
Royal College o
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
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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
NairobiKenya
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 reproductionrequires 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.
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CLINICAL AUDIT
for EFFECTIVE DELIVERY of
MATERNAL CARE IN KENYA
KEY POINTS
1. The audit process will assist in improving performance and effectiveness in clinicalpractice. 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 throughdiscussion with a multidisciplinary group of health care providers.
3. It is recommended that Clinical Audit for Effective Delivery of Maternal Care inKenya be used in conjunction with the companion publication Standards for Maternal
Care in Kenya.
4. It is hoped that the use ofStandards for Maternal Care in Kenya and this ClinicalAudit manual will assist health care providers to contribute to improvements in the
delivery of maternal and infant health services.
September 2003
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TABLE OF CONTENTS
PREFACE i
FOREWORD ii
ACKNOWLEDGEMENT iii
EXECUTIVE SUMMARY iv
LIST OF ABBREVIATIONS AND ACRONYMS v
CHAPTER 1 1
BACKGROUND
Introduction. 1
The Standards developed 2
Rationale for the choice of the Standards developed 2
Role of Clinical Audit Manual in implementing the Standards 2
CHAPTER 2 3
KENYA QUALITY MODEL
Concept of quality and quality improvement in health care 3
Kenya Quality Model 4
Quality improvement in maternal care in Kenya 5
CHAPTER 3 6
WHAT IS CLINICAL AUDIT?
Definition 6
Types of audit 6
Clinical audit and research 7
Ethical considerations in clinical audit 8
CHAPTER 4 10
THE PROCESS OF CLINICAL AUDIT
Developing standards 10
Setting up an audit team 11
Step 1: Choosing standards to audit 12
Step 2: Measuring current practice 13
Step 3: Feedback and identification of changes needed 16
Step 4: Implementing changes 20
Step 5: Re-evaluation of practice 21
CONCLUSION 23
NEXT STEPS 23
SOURCES AND SUGGESTED USEFUL READING 24
APPENDIX
Examples of audit cycle process from two pilot sites; Kenyatta National Hospital & Sabatia 25
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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. Select standards to audit
2. Measure current practice
3. Feedback and identify changes
4. Implement changes5. 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 BroekMrs. 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)
i
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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 importantbut 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 qualitymanagement (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).
iii
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EXECUTIVE SUMMARY
In the Standards for Maternal Care in Kenya manual the background to the Safe Motherhood Know-
How 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 co-
operation.
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 outcomerelevant to the standards. In the companion booklet on 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).
One of the aims of the Safe Motherhood Know-How Project was improving the competency of healthcare 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.
iv
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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 compare
DFIDUK Department for International Development United Kingdom
e.g. for example
i.e. that is
JSI-UK John Snow International, United Kingdom
KMOH Ministry of Health, Kenya.
KQM Kenya Quality Model
NJSC National Joint Steering CommitteeTBA Traditional Birth Attendant
TQM Total Quality Model
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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 abroad 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 offeredpotentially 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 initialthemes 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
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, wasformed 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 JSI-
UK 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
1
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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 criteriarelevant 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.
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 ofawareness of danger signs, was also considered
modifiable.
1 Kenya Demographic and Health Survey, 1998.2 Thaddeus & Maine 1994
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 simplemanner, 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 selectedstandards in diverse clinical settings in Kenya.
2
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3
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 forcontinuous 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 andtime-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 ofhealth 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 nursingand 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
2 Franco et al 1994
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 variousunits 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 indeveloping;
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.
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4
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 SystemsMonitoring 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 evidence-
based medicine (EBM) through wide
dissemination of public health and clinicalstandards and guidelines with total quality
management (TQM) and patient partnership
(PP). The issue of quality and quality
improvement is not addressed as a separateproject orset of add-on activities. KQM promotesquality 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 instandardization 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 self-
assessments by providers and external evaluation
by the Health Service Inspectors.
Additionally, the Department promotes TotalQuality 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 self-
assessment 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 HealthSystem that relates to its ability to satisfy
a stated or implied health need.
Quality Improvement in Health is aprocess:
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 qualitymanagement 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 forstandardization of provision of quality services in
the entire health care system in all settings in
Kenya.
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5
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 Deliveryof Maternal Care in Kenya and the Audit Report
must be viewed in the context of the broaderKenya Quality Model. To our knowledge, this
project represents the first effort to interpret and
implement the vision and mission of theDepartment 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 willbecome 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. Theseranged from the premiere National Teaching and
Referral Hospital at Kenyatta in Nairobi and in
the largest maternity hospital in Eastern Africa atPumwani, 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 healthservices and begin to implement the Ministry of
Health policy of continuous quality improvement.
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6
CHAPTER 3
What is Clinical Audit?
DefinitionClinical audit is the systematic review of the
quality of clinical care based on standards of careagreed 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 healthcare 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
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 isconcerned 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.
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,
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
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7
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 morbiditiesare 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 bedifficult 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 bothresearch 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
3 Smith 1992
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Box 1 compares and contrasts clinical audit and research.
Box 1: Research and Clinical Audit
Clinical Audit Research
Similarities 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
Differences Ensures correct use ofevidence
Based on standards
A cyclical and ongoing
exercise
Involves nothing beyond
normal clinical managementof patients
Convenience sample size
often used
Generates newevidence
Based on hypotheses
Has a definite finite
end
May involve
experiments onpatients
Based on a
scientifically valid
sample size
Source: Standards for Maternal Care in Kenya
Ethical Considerations in Clinical Audit
Audit involves appraisal of actual againstexpected 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 administratorsshould 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 toparticipate 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
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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 giveunfavourable 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 experienceswith this.
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10
CHAPTER 4
The Process of Clinical Audit
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:
o S specific
o M measurable
o A achievable
o R relevant
o 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 thenaudit them.
Measurement
II
Selectstandards
to audit
Measure
current practice
Measurement I
Feedback
and identify
changes
Plan and
implement
chan es
AUDIT
CYCLE
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Setting up an Audit Team
This is a crucial part of the process of clinicalaudit. 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 cancontribute 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
storyboardor 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; wesuggest 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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12
The clinical audit process has five steps:
Step 1: Choosing standards to audit
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 byan audit teamin 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 self-
assessment 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 candeliver 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.
Measurement
II
Select
standardsto audit
Measure current
practice
Measurement I
Feedback
and identify
changes
Plan and
implement
chan es
AUDIT
CYCLE
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Step 2: Measuring current practice
13
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 contributeto patient care relevant to the topic to be
audited.
Representatives from these sections shouldbe 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.
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 thisneeds 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.
Measurement
II
Select
standards
to audit
Measure
current practice
Measurement I
Feedback
and identify
changes
AUDIT
CYCLE
Plan and
implement
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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 fromdiagnosis 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.
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
o questionnaires - interviewer or
interviewee (self) administered
o key informant interviews
o focus group discussions
o client windows (as a strategy for
collecting qualitative data on
patient opinion)
Patient record reviewso 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 measurementwas 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.
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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 fewout 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 firstparticipant 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 isnot 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 theresources 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 fine-
tuning 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 datacollection. 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, thegeneral 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
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.
Measurement
II
Selectstandards
to audit
Measure currentpractice
Measurement I
Feedback
and identify
changes
AUDIT
CYCLE
Plan and
implement
changes
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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 worseor better than the agreed standard practice, based
on specific criteria. Presentation of results should
therefore bring out these discrepancies.
Identification of possible causes of
discrepancy
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
17
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?
SEEbox 2.
Structure criteria Process criteria Outcome criteria.
Appropriately skilled staff Appropriate staff are employed
and deployed
When a woman arrives at the
facility she is attended to by
a skilled health care provider
Accessible facilities
Staffs are present in the facility
or can be called immediately
Clear directions and signs Directions and signs are clearly
displayedGround floor facilities (if possible)
Client flow plan All staff in the health facility are
aware of the flow system
Delays at the health facility
are reduced. Long queues
become shorter
Uniform and ID badges Uniform and ID badges are worn
Informed and alert Receptionist Women are directed to the
appropriate unit by receptionist.
A fair and safe system of feecollection that does not prevent
access to care
Fees are collected after the
clients condition has stabilized
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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
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.
Box 3: Tools for Root Cause Analysis
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.
There are tools for enhancing group participation
during this phase of formulation of solutions.
An example is Brainstorming which is outlined in
Box 4.
Box 4: Brainstorming as a tool for generating ideas
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 Solvingand 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 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 orimpede 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
Stakeholder Analysis
In carrying out a stakeholder analysis, the
following steps are taken:
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 theaction and the source.
After all the changes have been effected it is
prudent to allow for some time to pass before re-
evaluating practice.
Measurement
II
to audit
Measure current
practice
Measurement I
Feedback
and identify
changes
AUDIT
CYCLE
Plan and
implement
chan es
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Step 5: Re-Evaluation of Practice
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.
Measurement
II
Select
standards
to audit
Measure current
practice
Measurement I
Feedback
and identify
changes
Plan and
implement
changes
AUDIT
CYCLE
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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 fromthe 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 interestedparties 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 manualscomposed 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 andsuggested 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 ProcessImprovement, Quality Assurance Methodology Series, Bethesda, MD, 1994.
Second (1997) edition available online at
Graham W, Wagaarachchi P, Penney G, McCaw-Binns A, Yeboah K, Hall M. Criteria for Clinical Audit of theQuality 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 SystemsMonitoring 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 throughCriterion-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.
The majority of patients admitted into the maternity wards are not booked for antenatal care
in Kenyatta Hospital itself.
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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 RATIONALE
1. A woman is given the choice
of having a companion during
antenatal clinic visit, labour and
postnatal clinic visit.
(General Standard of Care)
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 RECOMMENDED CHANGES
Inadequate input by the participating
obstetricians
Full participation by the obstetricians
Lack of recognition of the importance of the
medical records department at the beginning
of the project
Full recognition and participation of the
medical records department
Delay in seeking and getting clearance from
the Ethical and Research Committee of
Kenyatta National Hospital
Project proposal document with a letter
seeking clearance was sent to the Ethical
and Research Committee in July 2002.
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.
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
Lack of support to members of the audit
team by different arms of KNH
management:
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 alreadymore 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 malecompanion 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 shouldbe 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 Age Parity
ANC Marital Status Level of Education
1. Did you have a companion during: -
Antenatal clinic visits? Yes No
Labour? Yes No
2. Were you given information on the choice of having a companion during: -?
Antenatal clinic visits? Yes No
Labour? Yes No
Postnatal clinic visits? Yes No
3. Do you think it is (was) beneficial to be accompanied during your: -?
Antenatal clinic visits? Yes No
Labour? Yes No
Postnatal clinic visits? Yes 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 Clinical officer (Team Leader)
L. Songon Nursing officer
M Indete Nursing officer
C. Esilaba Nursing officer
B. Kirwa Laboratory Technologist
B. Kinzi Records Officer.
AUDIT PERIOD: January to October 2002.
STANDARDS SELECTED:
STANDARD RATIONALE
1. Every woman attending antenatal
clinic must have her blood pressure
measured, urine tested for protein and the
results recorded
(Pre- Eclampsia)
Need to ensure women with signs of pre-
eclampsia are identified
2. Every woman delivering in a health
facility will be monitored with a
partograph
(Prolonged Labour)
Improvement in the management of women
in labour was needed.
In Sabatia partographs were irregularly used
and inaccurately filled.
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).
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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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