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How to perform clinical audit?

Dr. Mithali Abdullah @ Jacquline Sapen


MSc. OSHM (UUM), M.B.B.S (Aust.), OHD (NIOSH), CMIE (NIOSH)
Timbalan Pengarah (Perubatan)II
Hospital Sultan Abdul Halim, Sungai Petani, Kedah

WHAT

HOW
WC

WHY

What is your cause?


What motivates you
to do clinical audit?
Source: Start with Why (2009) Simon Sinek

Road Map of talk


Revisit of Clinical audit
Clinical audit cycle
Stages in clinical audit

INTRODUCTION
Quality is not an accident, it is the result of
high intentions,

sincere efforts,
intelligent direction and
skillful execution

Clinical Audit

Clinical audit is a specific form of audit that


involves measuring clinical practice against
standards. An audit within the clinical setting
is not necessarily a clinical audit project.

Clinical audit would measure process( are


we doing the things we should do?)

Clinical audit could also look at outcomes:


such as monitor the success of a treatment
which is known to work, rather than to find
out whether it works.

Clinical audit vs Research


Clinical
Audit

Research

Ask the question are we following


agreed or evidence based practice?
Seek to find out if we are achieving the
things we agreed we should achieve

Ask the question what is the best


practice?
Researches will seek to find new
knowledge

Audit Cycle

The clinical audit process is known as the audit cycle.


Choose a
topic

Re-audit to
look for
improvement

Review
standard

Implement
change to
improve

Collect data
on current
practice
Compare data
collected with
standard

Source: NICE 2002

STAGES IN
CLINICAL AUDIT

Stages in clinical audit


Stage 1: preparation: management & methodology
Stage 2: selecting criteria and standard
Stage 3: measuring level of performance
Stage 4: making improvements
Stage 5: sustaining improvements

Stage 1: preparation
Good

preparation is crucial to the success of an audit


project.
If

you fail to plan, you plan to fail.

The

audit team should decide in advance the audit project


for the forthcoming year, time frame for data collection,
design and format of the necessary data collection tools.

Ref: Principals for best practice in clinical audit. National Institute for
Clinical Excellence. 2002. Radcliffe Medical Press Ltd.

2 areas to be considered in
preparation
Project management

Team
Leader
topic selection,
planning and resources,
communication

Project methodology
Study design
Data issue: collection,
analysis, storage
Implementability
Stakeholder
involvement: patients,
other HCW
Support for local
improvement

Stage 1: Step 1
PROJECT MANAGEMENT

The team

1.
2.
3.
4.
5.
6.

Identifying the skills and people needed to carry out the audit, and
training of staff and encouraging them to participate.
Involve the right people with the right skill from the start.
Certain skills are needed, which include:
Project leadership, Project management, project organization
Clinical, managerial, and other service input and output
Audit method expertise
Change management skills
Data management: data collection, data entry, data analysis, &
data presentation
Facilitation skills.

The Team

1.
2.
3.
4.
5.
6.

Audit team comprises :


staff from all relevant groups involved in the care delivery, audit staff
All audit team members:
must understand the processes of clinical care concerned
Must have a basic understanding of clinical audit
Understand the purpose of the audit
Committed to the plan and objectives of the audit
Understand what is to be expected of them specific roles &
responsibility: leader, data management, communication, etc.
Must understand the ground rules for meeting

The leader

The leader

Leadership is the art of getting someone else to do


something you want done, because he wants to do it.
~ Dwight D. Eisenhower

Topic selection
1.
2.

Involve users (health care providers or patients) in the


process
Based on SMART crtiteria

Involve users (health care providers or


patients) in the process

1.
2.
3.
4.
5.

Sources of user information:


Critical incident reports
Complaints or comments
Direct observation of care
Direct observations
Focus group discussion

Selection of topic: SMART

Seriousness: patient safety issues, high volume, high


risk, high cost
Measurable: any evidence-based standard, feasibility of
data management
Appropriateness: is the problem important? Is the
problem a priority?
Remediable: Is the problem concern amenable to
change?
Timely: should we deal with the problem now or later?

Defining the purpose of audit

1.
2.
3.
4.

The aims of the audit must be defined.


Key words that could be used include: to improve, to enhance, to
ensure, to change.
E.g. :
To improve blood transfusion process in the hospital
To ensure that Safe Surgery Save Life Initiative is implemented
To enhance the referral of stroke patients in the hospital
To increase the percentage of patients with controlled blood
pressure.

Purpose of audit
What aspects of care that concern us?
Which aspect of care that you would like to
audit?

Effectiveness

Is the treatment being administered


correctly & does it have the desired
effect?

Efficiency

Is this approach achieving the desired


outcome with minimal effort, expense, &
wastage ?

Equity

Do all patients have equal access to care?

Purpose of audit
Accessibility

Is it easy for patients to get


treatment? Waiting time?

Appropriateness

Is this the right management


approach?

Acceptability
Timeliness

Is the treatment acceptable to


patients? As per standard/guideline?
Is the care being provided at the
correct time?

Providing the necessary structure


1.

2.

A structured audit program is needed: committee structure,


feedback mechanism, regular audit meeting
A team of well-qualified audit staff.

Funding is important.This include resources for staff training &


administration, knowledge of clinical audit technique, data
management.
Time is another important barrier in successful audit. Participants
should be given the time to participate in the project.

Communication
Inform all those who are going to be involved.
Platforms for communication include:
memo/letter, e-mail, meeting

Stage 1: Step 2
PROJECT
METHODOLOGY

Project methodology

Design of study: retrospective , prospective, cohort, case


studies, case review
Data collection: what, where, when, how
Sample : subjects to be selected. Inclusion & exclusion
criteria
Sampling technique & sample size
Type of data analysis: qualitative, quantitative

Study design: retrospective or cross


sectional data collection
1.

2.

Retrospective data collection:


look at previous records.
Could be difficult to trace relevant records.
Time consuming
Relevant information required may not be available: incomplete
records
Cross sectional data collection:
gives audit team more immediate feedback on its current
performance
Relevant information required would be easier to retrieve:
health care providers informed prior to study on documentation
of information.

Data collection
What: collect data that is related to audit criteria
Who(samples) from whom these data is gathered?
Patients? Healthcare providers? Inclusion/Exclusion
criteria
Who: by trained staff.
Where: unit/department

Data collection

When: inpatient, outpatient, on admission, after


discharge, during administration of medicine, during
observed procedure?
How: include observational checklist, questionnaires
(self-completed or interviewer completed), patient
medical records, interviews
Data storage: data collection format

An Audit on the
Use of Granisetron Injection for
Chemotherapy-Induced Nausea and Vomiting
in Hospital Sultanah Bahiyah
Pharmacy Department
Supervisor : Malathi Sriraman @ Jayaraman
Group Leader : Chan Huan Keat
Group members: Khor Seau Ting
Tan Say Li

Data collection pertaining to audit criteria


Quality of Care Selected
Rational use of granisetron injection in terms of:
(a) Indication.
(b) Dose.

Audit Criteria & Standard


NO

Quality of Care

Criteria

Standard

1.

Indication of
granisetron
injection

Only prescribed in moderately and highly


emetogenic chemotherapy unless it is justified.

100 %

Dose of
granisetron
injection

Only prescribed at the lowest effective dose, which


is 1mg or 0.01mg/kg unless it is justified.

100%

Ref. Systemic Therapy of Cancer 2nd Edition, Ministry of Health Malaysia, 2007.
34

Objective 1: To determine the adherence of prescribers to recommended


indications and doses of granisetron injection by the updated guidelines.

Study
Design

Prospective study:
To check prescriptions for adherence to the
recommended indications & doses.

Inclusion
Criteria

All adult chemotherapy prescriptions


prescribed with granisetron injections
received from Jan-Mac 2011.

Exclusion
Criteria

Prescriptions with incomplete information.

Population
Size

N = 432 prescriptions.
All included.

Data
Collection

1. Receive & screen the prescriptions.


2. Record the required information
into Data Collection Form A.

Data
Analysis

SPSS 16:
(a) Descriptive analysis.
35

Data collection

You may like to know the factors that contribute to


substandard performance such as knowledge,
perception and practice.
Thus, design data collection tool to collect such data.
Include questionnaire (patients or HCW) &
observational checklist (to determine if knowledge is
translated into practice)

Objective 2: To assess prescribers perception of the granisetron


injection utilization in the prevention of CINV.
Study
Design

Cross-sectional study:
To study the prescribers perception using a
validated questionnaire modified from
Tajunisah M.E. et al (Cronbachs = 0.72). 8

Inclusion
Criteria

All doctors in 10 wards that provides


chemotherapy during Jan-Mac 2011.

Sampling
Method

Convenient sampling.

Sample
Size

n = 63 doctors.

Data
Collection

1. Distribute Data Collection Form B (selfreported questionnaire) to wards.


2. Collect the forms back after completely
answered by doctors.

Data
Analysis

SPSS 16:
1. Descriptive analysis.
2. Inferential analysis: Chi Square tests.

8. Tajunisah M.E. et al, Physicians Perception and Adherence to Guideline on the Management of Chemotherapy
Induced Nausea & Vomiting (CINV).
Hospital Pulau Pinang, 2009.
37

PATIENT FALLS AUDIT FORM. 003/HSAH/UKL

Names of Auditors:___________________
Ward/Department:____________________
Date:_______________
1.
2.
3.
4.
5.
6.
7.

8.

BHT
1

BHT
2

BHT
3

BHT
4

BHT
5

BHT
6

Has fall risk assessment been completed


within 48 hours of admission?
Is level of risk for fall documented in the
record?
Is there an appropriate care plan for the
patient based on the level of risk?
Is there evidence that the patient has been
reassessed accordingly?
Is there evidence that there is action plan to
reduce risk of falling?
If a fall occur, is there any evidence of the
circumstances surrounding the patient?
For a patient who has fallen, is there any
evidence that other strategy have been
implemented?
Is there any evidence that doctors/
physiotherapist/occupational therapist have
been involved?
Total
%

Adapted from Barnet, 2001.

3 August 2009

BHT
7

BHT
8

BHT
9

BHT
10

Total %

Data protection

Data collection procedure must be ethical


When data is obtained directly form patients, auditors must explain
why the information is needed and what will happen to it, before
asking the patients consent.
If the information is obtained from medical records:
i) patients consent to the retrieval of records and data being used
or
ii) data should be made anonymous before the audit start
or
Obtained ethical approval from national ethic committee.
Confidentiality of data

Stage 2
SELECTING CRITERIA
& STANDARD

Stage 2: selecting criteria & standard

Clinical audit is a specific form of audit that involves measuring


clinical practice against standards
So, there must be criteria and standard.
Criteria: i) explicit statement that define what is being measured
ii) represent elements of care that can be measured
objectively

Criteria: an item or variable which enables the achievement of a


standard & the evaluation whether it have been achieved or not
Standard: level of care that need to be achieved for the particular
indicator.

Criteria

1.
2.
3.

Classified into:
Structure: what you need
Process: what you do
Outcome: what you expect

Criteria

1.
2.
3.

Structure: include
staff: no. of staff, skill mixed, ratio of staff to patients.
Equipment: technology, number of equipment
Space provided: number of OT functioning, room for
counseling

Criteria

1.
2.
3.
4.
5.
6.
7.
8.

Process refer to actions & decision by healthcare providers


Communication
Assessment
Education
Investigation
Prescribing
Therapeutic intervention
Evaluation
Documentation

The importance of process criteria is determined by the extent


to which they influence outcome.

Department

KPI

Anesthesiology Percentage of
Elective And
Emergency Surgery
Patients Who
Receive Acute Pain
Service

Standard

Achievement

>10%

5.1%
(204/4001 x
100%)

Process Criteria: pain assessment

Criteria

Outcome criteria are typically measures of physical or


behavioral response to an intervention, reported health
status, level of knowledge and satisfaction

More often proxy or intermediate outcome criteria are


used.

Outcome Criteria

Department

Dietetic &
Catering

NIA

Standard

Incidence of Physical
Contamination of Food
Served to Patients

Sentinel events

Indicator: Delay in
Response to In-patient
Referral by Dietitian
(for critical case)

Achievement

2 cases

Standard : 5
%

Process Criteria: referral process

6.1%
(25/407 X 100%)
(Repeat SIQ. 11.8%:
Jul-Dec 2009)

How to develop valid criteria?

1.
2.
3.
4.
5.
6.

Valid criteria must meet the following:


Evidence based
Related to important aspects of care
Measurable
Specific
Achievable
Relevant

How to develop valid criteria?

1.
2.
3.

Sources for developing criteria:


Existing guidelines: clinical practice guidelines (CPG),
national policy
Systematic literature review relevant to topic
Review of other practices elsewhere (when you
cannot find information in the literature)

Stage 3
MEASURING LEVEL OF
PERFORMANCE

Stage 3: measuring level of performance

Data storage
Data analysis
Comparing performance with standard
Any gap in performance (short fall in quality, SIQ)

Data analysis: compare with standard


NO Quality of Care
1.

Indication of
granisetron
injection

Low Emetogenic
(Level 1&2)

38.0%
(164 Rx)

Criteria

Standard

Only prescribed in moderately and highly


emetogenic chemotherapy unless it is justified.

100 %

Moderate Emetogenic
(Level 3)

19.9%
(86 Rx)

38% non-compliant to
indication

42.1%
(182 Rx)

High Emetogenic
(Level 4)

52

Data analysis: compare with standard


NO Quality of Care
2

Dose of
granisetron
injection

Criteria

Standard

Only prescribed at the lowest effective dose,


which is 1mg or 0.01mg/kg unless it is justified.

100%

0.7% Granisetron 1mg


(3 Rx)

Only 0.7% compliant to


dose of 1 mg
99.3%
(429 Rx)

Granisetron 3mg
53

Stage 4

MAKING
IMPROVEMENT

Stage 4: making improvement


Analysis of problems: why is there a gap in
performance?
Identify areas to improve
Formulate strategies to overcome problems
Communicate action plan
Implement strategies
Evaluate strategies

SIQ

Is there gap in performance?


Is the gap in performance real?
Exclude error in data collection: inclusion criteria,
exclusion criteria, data analysis, data entry, data
calculation

Identify areas to improve


Conduct root cause analysis
Could be done earlier during data collection: has been
discussed in project methodology.
Literature review helps in identifying causes for
substandard performance.
Data collection tools designed to measure these causes:
knowledge, perception & practice

To assess prescribers perception of the granisetron injection utilization


in the prevention of CINV.
Prescribers perception:
Why are guidelines not widely-adapted in HSB
practice?
Lack of awareness
33.3% (21)
Lack of guideline availability
36.5% (23)
Lack of guideline enforcement
42.9% (27)

n=63 prescribers

There are no association between prescribers perception and all the factors tested including
departments and clinical experiences (p>0.05).
58

Formulate strategies to overcome


problems
Targeted
root cause

What to
change

How to
change

When to
change

Who is
responsible

Stage 1 of strategy for change


Targeted contributing
factors

AWARENESS

What to change?

To improve the awareness among the


prescribers and pharmacists.

How to change?

At INDIVIDUAL level:

CME to update the prescribers on the


latest guidelines.

CPE to educate the pharmacists on the


chemo prescriptions screening.

When to change?

2 months (Nov Dec 2011).

Who is responsible?

CDR Pharmacy unit.


DIC Pharmacy unit.

Stage 2 of strategy for change


Targeted contributing factors

GUIDELINE AVAILABILITY

What to change?

To ensure updated guidelines are


available in all the related wards and
daycare clinics.

How to change?

At PRACTICE SITE level:

To distribute the updated


antiemetic guidelines in poster
form to facilitate the rational
prescribing among the prescribers.

When to change?

2 months (Jan Feb 2012).

Who is responsible?

CDR Pharmacy unit.


Hospital Health Education Unit.

Stage 3 of strategy for change


Targeted contributing factors

GUIDELINE ENFORCEMENT

What to change?

To ensure the adherence to the


antiemetic guideline in the hospital.

How to change?

At SERVICE level:

Order form to require justification


from oncologists/ specialists in
non-indicated or high dose cases.

CDR unit to prepare granisetron


injection in 1mg syringe form to
encourage the use of low dose.

When to change?

2 months (March April 2012).

Who is responsible?

CDR Pharmacy unit.

Communicate action plan

What to tell: why audit is done, problem statement,


criteria & standard, major & important findings,
strategies for change
How to communicate
Who to tell
When to tell
Where to tell

Communicate action plan


Many ways to do this:
1. meeting: intra-department, inter-department, hospital
level, state level
2. Training session: CME/CPD, seminar
3. Memo/letter
4. Bulletin, newsletter
5. Information board
6. E-mail

Present clinical audit and findings & what to do to improve


the performance

Implement strategies
Strategies for CHANGE is all about CHANGE
Observe the stages for change

Awareness

Agreement

Acceptance

Assimilation

Accountability

Action

Stage 5: sustaining improvement


Do another cycle of data collection and analysis
Do trending of performance

4 kinds of motivation
Do this clinical audit
& youll get a bonus

I really want to do this


clinical audit

I really dont want to


Do this clinical audit or
do this clinical audit
youll get low mark on
your annual appraisal
Negative
Motivations away from something

+
Intrinsic
You want to do it

Extrinsic
Someone wants you to do it

Positive
Motivations towards a goal

+ only this one

create positive,
sustainable
motivation

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