Clinical Audit for Effective Delivery of Maternal Care in Kenya

7/31/2019 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)

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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.

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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

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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.

9


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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


21/41

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.

11


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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


23/41

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


24/41

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.

14


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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

16


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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


28/41

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

20


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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

21


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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.

23

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



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:



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: -?


Labour? Yes No

Postnatal clinic visits? Yes No

3. Do you think it is (was) beneficial to be accompanied during your: -?


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



During the first measurement 100 % of cards had a blood pressure measurement recorded

and 77% had urinalysis performed and recorded.


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



A regular supply of urine dipstix was put in place

The cost of antenatal profile was reviewed by Health Centre Development

Committee


Staff needed to be updated in the use of the partograph

Supply of partographs was not continuous

CHANGES IMPLEMENTED




All staff were re trained in the use of the partograph

Continuous supply of partographs was ensured

MEASUREMENT 2



During the second measurement 99% of antenatal records had a blood pressure measurement

recorded and 79% had urinalysis recorded.

Documents

Clinical Audit for Effective Delivery of Maternal Care in Kenya