CLINICAL AUDIT GUIDELINE 2023 MEDICAL CARE QUALITY SECTION MEDICAL DEVELOPMENT DIVISION MINISTRY OF HEALTH MALAYSIA
0 CLINICAL AUDIT GUIDELINE 2023 All copyrights reserved © Ministry of Health Malaysia. No part of this guideline may be reproduced or transmitted, in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage or retrieval system, without prior permission from the Publisher. Completed in December 2022 Published in July 2023 Clinical Audit Unit, Medical Care Quality Section Medical Development Division Ministry of Health Malaysia Block E1 Complex E Federal Government Administrative Centre 62590 Federal Territory of Putrajaya Malaysia A copy of this guideline is also available online at MOH Portal: https://hq.moh.gov.my/medicaldev/ckpp/unit-audit-klinikal/ A catalogue record of this document is available from the National Library of Malaysia. i
1 FOREWORD am honoured to introduce this Clinical Audit Guideline 2023, a testament to the dedication and commitment of our healthcare professionals towards delivering high-quality care. In an everevolving landscape where patient safety and quality improvement are paramount, clinical audit plays a pivotal role in ensuring the effectiveness of our practises and driving positive change. A clinical audit represents a systematic, rigorous examination of healthcare processes and outcomes against predetermined standards or criteria. Its purpose is to assess and enhance the quality of care provided, promote evidence-based decision-making, and ultimately improve patient outcomes. This audit serves as a platform to showcase the collaborative efforts and commitment of our multidisciplinary team to transparency and accountability. It is an evidence to the synergy and shared vision that exist within our healthcare setting, as we work towards a common goal of delivering the highest standard of care. Each individual involved, from clinicians to administrators, plays a crucial role in contributing to the success of this clinical audit and the betterment of patient care. By acknowledging the gaps in our practises and embracing the challenges they present, we demonstrate our unwavering commitment to providing safe, effective, and patient-centred care. It is imperative that we approach clinical audit with an open mind and ready to embrace new insights and perspectives. It is within these moments of introspection and self-reflection that we have the greatest potential for transformative change. I extend my heartfelt appreciation to all those involved in this Clinical Audit Guideline 2023, especially the Clinical Audit Unit, who have diligently contributed their time and expertise. Your dedication and commitment to quality improvement are invaluable, and your efforts are instrumental in shaping the future of healthcare delivery. May this clinical audit serve as a catalyst for positive change, fostering a culture of continuous improvement and innovation. Together, let us seize this opportunity to create a lasting impact on the lives of the patients we serve and strive towards a healthcare system that consistently delivers exceptional care. Datuk Dr. Muhammad Radzi bin Abu Hassan Director General of Health Ministry of Health, Malaysia June 2023
2 PREFACE linical audit is a powerful tool for assessing and improving the quality of healthcare services. Within these pages, we explore the fundamental concepts and methodologies of clinical audit, while emphasising its importance in today's rapidly evolving healthcare landscape. It aims to provide healthcare professionals, administrators, policymakers, and other stakeholders with a holistic understanding of clinical audit and its potential to drive positive change in healthcare settings. The primary objective of clinical audit is to ensure that healthcare services consistently meet established standards, optimise patient outcomes, and provide safe and effective care. It offers a systematic approach to evaluating clinical practise, identifying variations, and implementing evidence-based changes that enhance the quality of care delivered. It is important to note that clinical audit is not a standalone process but an integral part of a broader quality improvement framework. By aligning and integrating clinical audit with organisational priorities, accreditation standards, and national guidelines, healthcare institutions can foster a culture of continuous improvement and ensure the provision of high-quality care to create a robust system that drives sustainable change and improves healthcare outcomes. Ultimately, the success of clinical audits relies on the commitment and collaboration of all stakeholders. From healthcare professionals at the bedside to administrators and policymakers, each individual plays a vital role in embracing the principles of clinical audit and championing its implementation in healthcare settings. As we embark on this journey through the world of clinical audit, I encourage everyone of us to approach it with an open mind and a dedication to excellence. Together, let us harness the power of clinical audit to transform healthcare systems, improve patient safety, and deliver the highest standards of care. Dato’ Dr. Asmayani binti Khalib Deputy Director General of Health (Medical) Ministry of Health, Malaysia June 2023
3 ADVISORS DR MOHD AZMAN BIN YACOB Director Medical Development Division DR NOR HAYATI BINTI IBRAHIM Deputy Director Medical Care Quality Section Medical Development Division SECRETARIAT CLINICAL AUDIT UNIT Medical Care Quality Section Medical Development Division DR FAIZAH BINTI MUHAMAD ZIN Head of Clinical Audit Unit DR ZAWANIAH BINTI BRUKAN ALI Senior Principal Assistant Director DR AHMAD HARIZ BIN MOHAMAD Principal Assistant Director DR LAVANYA A/P GUNASAKARAN Principal Assistant Director PUAN SERIPAH NOR BINTI MAT NOR Head Nurse
4 CONTRIBUTORS CLINICAL AUDIT TECHNICAL WORKING GROUP (TWG) 2019 – 2020 Dato’ Dr. Norsidah Binti Ismail Dr. Paa Mohamed Nazir Bin Abdul Rahman Dr. Nor’Aishah Binti Abu Bakar Dr. Azmi Bin Alias Dr. Hung Liang Choo Dr. Saiful Safuan Bin Md Sani Dr. Zaharimah Binti Abdul Kadir Dr. Norjehan Binti Yahaya Dr. Raja Zarina Binti Raja Shahardin Dr. Mithali Abdullah @ Jacquline Sapen Dr. Maizun Binti Mohd Zain Dr. Nur Mastura Binti Aliyasaa’ Dr. Anith Shazwani Binti Adnan Pn. Rohana Binti Omar Pn. Aidaliani Binti Ghazali
5 TABLE OF CONTENT No Topic Page 1. What is Clinical Audit? 6 2. Scope 9 3. Objectives 9 4. Roles and Responsibilities 4.1 National Level 10 4.2 State Health Department 10 4.3 Hospital/ Organization 11 5. Workflow and Reporting of Clinical Audit 12 6. Client Charter 14 7. Ethics 15 8. Consent 16 9. Training 16 10. Monitoring 17 11. Clinical Audit Cycle 11.1 Select topic and form a team 19 11.2 Set standards and methods 20 11.3 Compare practice with standards 22 11.4 Change practice 23 11.5 Re-audit to make sure practice has improved (closing the loop) 24 12 Reference 25 13 Appendix Clinical Audit Report Clinical Audit Plan of Action Clinical Audit Marking Scheme 2023
6 1. WHAT IS CLINICAL AUDIT? 1.1. Clinical audit is a component of clinical governance that offers the greatest potential to assess the quality of care. Clinical governance is defined as: (Department of Health, Welsh Office 1998) 1.2. The National Institute for Clinical Excellence (NICE) has defined clinical audit as: (Principles for Best Practice in Clinical Audit – NICE, 2002) 1.3. According to the National Health Service (NHS), England clinical audit is defined as: (High Quality Care for All: NHS Next Stage Review, 2008) 1.4. Clinical audit is a process of healthcare professionals evaluating the quality of care they provide, as a team, by comparing current practice against the best practice. The results will show whether things are being done in accordance with the best practice. "A framework through which National Health Service (NHS) organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish." “A quality improvement process that seeks to improve patients care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated changes are implemented at an individual, team or service level and further monitoring is used to confirm improvement in healthcare delivery.” “A way to find out if healthcare is being provided in line with standards and let care providers and patients know where their service is doing well, and where there could be improvements. The aim is to allow quality improvement to take place where it will be most helpful and will improve outcomes for patients. Clinical audits can look at care nationwide (national clinical audits) and local clinical audits can also be performed locally in trusts, hospitals or GP practices anywhere healthcare is provided.”
7 1.5. NHS defines quality as care that is effective, safe and provides as positive an experience as possible. This set out three dimensions, which must all be present to provide a high-quality service (Diagram 1): Patient experience: quality care is delivered for a positive experience, including being treated according to individual wants or needs, and with compassion, dignity and respect Patient safety: quality care is delivered to prevent all avoidable harm and risks to individual safety. Clinical effectiveness: quality care is delivered according to the best evidence in improving an individual’s health outcomes. Diagram 1: The three dimensions of high-quality care service
8 1.6. Types of Clinical Audit Figure 1: Types of Clinical Audit 1.7. Comparison between Clinical Audit and Research Characteristic Clinical Research Clinical Audit Purpose Prove Improve Character Scientific Inquiry Systematic measurement Function Sets standards Compare standards Sample size Statistical significance Commitment to Act Bases for measurement Testing hypothesis Standard of practice Methods New treatment No new treatment Outcome Increased knowledge Improved practice Table 2: Comparison between Clinical Audit and Research Research asks, “Are we singing the right song?” Clinical Audit asks, “Are we singing this song, right?”
9 2. SCOPE This Clinical Audit Guideline serves as a reference and applies to all Ministry of Health (MOH) employees who are responsible in the management of patients and the personnel involved in managing the direction and development of clinical audit. It requires commitment from all healthcare providers to achieve its purpose. 3. OBJECTIVES 3.1. This guideline aims to: educate and increase the awareness of the healthcare providers in understanding clinical audit. act as a guide for the healthcare providers to carry out a clinical audit at their organisation. ensure the best clinical practices are being practice at the healthcare facilities through the implementation of clinical audit. 3.2. The purpose of this guideline is to establish a framework for conducting a clinical audit. It includes: • developing and designing clinical audit projects; • completing the audit cycle through action plans; • sharing the good practice within the MOH. 3.3. Clinical audit activity undertaken in MOH healthcare facilities must comply with the requirements of this guideline.
10 4. ROLES AND RESPONSIBILITIES 4.1. National Level ROLES RESPONSIBILITIES Clinical Audit Unit MOH Clinical audit promotional activity. Organize training and capacity building in clinical audit activity at the national level. Review the feasibility and the applicability of the guideline from time to time. Surveillance of the clinical audit activity at the national level. Compilation of clinical audit reports from the State Health Department. Share and disseminate information on clinical audit to the stakeholders. 4.2. State Health Department ROLES RESPONSIBILITIES State Health Director/ Deputy State Health Director Responsible for the implementation of clinical audit activity in the state according to guideline. Responsible for promoting, supporting and monitoring clinical audit activity at the state level. Responsible to share and disseminate information on clinical audit at the state level. Appoint State Clinical Audit Coordinator. State Clinical Audit Coordinator Champion of clinical audit activity in the state. Responsible for promoting, supporting, coordinating and monitoring clinical audit activity at the state. Compilation of the clinical audit reports of the state. Responsible to liaise with Clinical Audit Unit MOH concerning clinical audit activity.
11 4.3. Hospital/ Organization ROLES RESPONSIBILITIES Hospital Director/ Director of the healthcare facility Act as an advisor and facilitate the Clinical Audit activity in the hospital/ organization Hospital Deputy Director/ Deputy Director of the healthcare facility Responsible for the local implementation of this guideline in the organization and reports to State Health Department. Establish a Clinical Audit Committee in the organization. Appoint a Clinical Audit Coordinator for the organization. Ensures that Clinical Audit Committee carry out their responsibilities for the success of the clinical audit activity. Head of Department Responsible for the implementation of this guideline in the department. Responsible in ensuring clinical audit activity is being carried out on the department. Ensures the involvement of the member in the department in the clinical audit activity. Ensure the implementation of the improvement measures identified from the clinical audit activity. Quality Unit Manager of the Hospital/ Facility Responsible for facilitating the implementation of clinical audit activity in the hospital/ organization according to the guideline. Responsible for facilitating and supporting the promotion and monitoring of the clinical audit activity in the hospital/ organization. Clinical Audit Coordinator of the Hospital/ Facility Champion of clinical audit at the healthcare facility. Responsible for promoting, coordinating, training and monitoring of the clinical audit activity in the healthcare facility. Clinical Audit Committee of the Hospital/ Facility Comprises of clinicians and healthcare providers who are responsible for delivering care and treatment at their respective department/ area. Champion of clinical audit at the healthcare facility. Responsible to assist in promoting, coordinating, training and monitoring of the clinical audit activity in the healthcare facility. Responsible of conducting the audit at the respective department/ area.
12 4.3.1. Clinical Audit Committee POSITION Advisor Hospital Director/ Director of the Facility Chairman Deputy Director of the hospital/ facility Coordinator Clinical Audit Champion - Clinicians or Medical Administrator or Medical Officer or Pharmacist or Allied Health Professionals or Paramedics Members Healthcare providers who are responsible for delivering care and treatment at the hospital/ facility, including the Quality Officer.
15. WORKFLOW AND REPORTING OF CLINICAL AUDIT Diagram 2: Workflow and
3 d Reporting of Clinical Au
14 6. CLIENT CHARTER • The MOH acknowledges clinical audit is a component of clinical governance. • The MOH is committed in using clinical audit as one of the tools in the quality improvement activity in the MOH facilities. • Clinical audit is part of the good clinical practice. • Clinical audit shall be a culture in the MOH organization. • The MOH shall provide support in terms of technical assistance, resources, capacity building as well as implementation of intervention if feasible. • This Clinical Audit Guideline is consistent with the MOH commitment to Patient Safety and Quality in improving clinical services. • This Clinical Audit Guideline must be reviewed every five (5) years.
15 7. ETHICS 7.1 In determining the choice of clinical audit project, discrimination based on ethnicity, disability, gender, age, sexual orientation, religion and belief should be avoided. 7.2 Clinical audit project does not need to be submitted to the local Research Ethics Committee for ethical approval. However, clinical audit must always be conducted within an ethical framework. If the Clinical Audit Committee has any concerns regarding the ethics which involves patient’s sensitivity in any aspect of the clinical audit activity, consultation with the relevant Ethics Committee is mandatory. 7.3 Ensure patient confidentiality at all times by abiding by the Malaysian Personal Data Protection Act 2010. 7.4 The data collected should be anonymized wherever possible, removing identifiers such as patient/ service username or other unique/ semi-unique details such as postcode, date of birth etc. Data should be collected using an identification code. 7.5 Any patient-identifiable clinical audit data must be kept secure, e.g. by locking audit proformas away in a filing cabinet or password protecting electronic files. 7.6 Once the audit has been carried out and written up, all completed audit proformas and patient identifiable data should be destroyed after seven (7) years of storage under lock and key. 7.7 Clinical audit only needs ethical approval if the audit involves anything being done with patients which would not otherwise be part of their routine clinical management. 7.8 Clinical audit needs to be registered to National Medical Research Register (NMRR) if the project is planned to be submitted for publication or to be published at any journal or any international platforms.
16 8. CONSENT 8.1 Where an audit requires information to be collected directly from patients, consent should be obtained verbally and recorded in the data collection form. 8.2 Consent is not required to access patient records for criterion-based clinical audit. - A criterion-based audit is a specific form of clinical audit that can be effectuated by non-medically qualified audit assistants who screen the medical records of patients and extract relevant data. Standardized criteria for evaluating good quality of care are previously determined and then compared against patients’ medical records to evaluate whether a minimal standard of care has been met. 9. TRAINING 9.1 A good understanding of the importance and benefit of clinical audit is essential in promoting and establishing clinical audit as part of the organizational culture. 9.2 Clinical Audit Coordinator will be appointed in the health care facility. The coordinator shall provide technical advice and consultation in conducting clinical audit activity. 9.3 Healthcare providers need to be trained in clinical audit and improvement strategies.
17 10. MONITORING 10.1 The Quality Unit in the healthcare facility is responsible for monitoring the clinical audit activity in terms of progress and outcome of the audit. 10.2 The purpose of monitoring is to offer assistance if necessary. 10.3 Following completion of clinical audit, action plan and implementation strategies for improvement need to be conducted by the respective unit/ department and monitored by the Quality Unit and the Clinical Audit Committee of the healthcare facility. 10.4 There is no registration needed at the national level to start a clinical audit, as it is part of the good clinical practice in the hospital/ organization. If one plans to expand the clinical audit as research, please consult the hospital Clinical Research Centre. However, the clinical audit activity records must be maintained and kept at the hospital level and the JKN level.
18 11. CLINICAL AUDIT CYCLE Diagram 3: The Clinical Audit Cycle The clinical audit cycle include: 1. Select topic and form a team 2. Set standards and methods 3. Compare practice with standards 4. Change practice 5. Re-audit to make sure practice has improved (closing the loop) Set standards and method
19 11.1 Select Topic and Form a Team The topic for audit must be prioritised to accommodate organisational, local and national agendas whilst avoiding duplication of effort. As resources for carrying out audits are finite, care should be taken in identifying and prioritising suitable audit topics. When planning the audit topic and determining priorities, consideration should be given to: - Team priorities - Adverse events - Claims or litigation - New policies or guidelines implemented - Trends from quality indicators - Mortality and/ or morbidity data - Re-audit requirements - Findings from inspections and investigations - Local concerns - complaints, surveys, letters, focus groups, patient stories The team members must include those who are involved in patient care whether within or outside the organization or department and it is important to ensure that everyone is represented in the project team with the agreement of the stakeholders. It is important that the clinical audit project is supported by the administrators and who have the authority to make improvement or change. The objectives of the clinical audit project must include what to achieve, i.e. the overall purpose of the project in comparing the current practice against explicit criteria. It should be phrased positively to ensure that the audit brings about improvements in practice.
20 11.2 Set Standards and Methods Standards of best practice may exist locally or nationally in the form of guidelines or protocols. National standards are available for certain treatments and conditions in the form of Clinical Practice Guidelines by the Ministry of Health or other professional bodies. If there are no recognised standards available from these sources, audit specific standards need to be developed by the clinicians undertaking the audit and this can be done through meetings or consensus basis. The standards should relate to the audit objectives and should always be based on the most up-to-date evidence of what constitutes best practice. A literature search will need to be undertaken to identify relevant evidence from which to develop the standards. Set standard based on explicit criteria (which may include the inclusion and exclusion criteria) that can be measured feasibly by the clinical audit design. Figure 2: Setting the Clinical Audit Standard and Criteria Target of the standard should be based on the agreed guidelines or protocol or a national target. However, it can also be set at a lower level from what that is which was taken from a baseline audit or the most you can aim at in the current circumstances.
21 Methods Always do a pilot by looking at a few patients or cases or records. Design the audit according to what has been agreed upon by the team. Check whether the audit design works by testing it on a few cases. If it doesn’t, re-design and pilot again. Audit Design Can be a concurrent, retrospective, or prospective audit. Should include: What data? Where to collect? Who will collect? How much data? How long the data will be collected? What resources will be needed? Ways of collecting data Patient’s notes Interviewing patients of staff Questionnaires Recording when an event occurs Observing practice Looking at policies and minutes The data collected should enable the team to measure practice against the standards. Sample Size In clinical audit, the sample size needs to be a fair sample that represents all the patients or cases or records based on the clinical audit project. Not necessarily big or statistically significant. Random sampling, convenience or universal sampling may be used depending on the agreement of the team member and the audit design.
22 When questionnaires are used, the questionnaires should: Use simple language and avoid jargon. Clarify abbreviations. Avoid leading questions which suggest a particular answer. Keep the questions simple, which means, one question for one answer. Give a section for comments, but, if possible, try to collect most information using set responses. 11.3 Compare Practice with Standards This includes data analysis whereby the analysis should establish which standards are being met and which are not. If a standard is not being met, the team need to identify why and how practice can be improved to ensure that the standard is met in the future. The team may also consider if there were other, acceptable reasons for the standard not being met, i.e. an exception not considered during the planning stage. Data analysis Use a tool that the team are happy and comfortable with This may be pencil and paper and a calculator or a simple spreadsheet. Use simple descriptive statistics (e.g. averages, percentage and ranges), not necessarily to use inferential statistical tests. Figure 3: Calculation of result
23 11.4 Change Practice The findings of the audit should be discussed by the project team and presented to the stakeholders. Projects should be presented both verbally and written up as a report. It should address how well the standards are being met and highlight any problems The presentation should generate discussion and agreement about changes to practice considering the audit results. If full compliance with the standards was not achieved an action plan should be developed to address any issues. It should include an action plan with recommendations, actions, responsibilities, and timescale for implementation and all the information needed to plan for a re-audit. Identify who will review how the action plan is going (refer Appendix). When discussing and deciding on possible solutions, consider: Who will be involved What or which will lead to change What and which are feasible and acceptable to staff and patients When is the best time to implement? Where appropriate (place) Why does the solution need to be done? How does the solution will be carried out?
24 11.5 Re-audit to make sure practice has improved (closing the loop) If the audit shows that current practice needs to be improved, making changes is important. Repeat the audit (re-audit) to ensure that changes have been implemented and made the difference you expected in ensuring that the practice has improved. Do not re-audit until changes have been made. The re-audit should use the same design as the initial audit. Only re-audit standards where changes have been made If the re-audit shows you meet the standard, the loop has been closed. It is good practice to repeat the audit after a period of time (for example a year) to ensure the improvements have been sustained and can be used for surveillance purposes.
25 REFERENCE 1. High Quality Care for All: NHS Next Stage Review, Department of Health, (2008) www.gov.uk/government/uploads/system/uploads/attachment_data/file/228836/7432.p df 2. Developing A Clinical Audit Policy, Healthcare Quality Improvement Partnership (November 2016) https://www.hqip.org.uk/wp-content/uploads/2018/02/developing-a-clinical-auditprogramme.pdf 3. A Brief Introduction on Clinical Audit Cycle, UHBristol Clinical Audit Team (2017) https://www.uhbristol.nhs.uk/media/2978735/2_introduction_to_the_clinical_audit_cycl e_v4.pdf 4. Clinical Audit Handbook, Kedah State Health Department (2016) https://jknkedah.moh.gov.my/images/penerbitan/Clinical_Audit_Handbook.pdf
APPENDIX
Clinical Audit MOH 2023 CLINICAL AUDIT REPORT* Title : Department : Hospital/ Clinic : State : 1. Topic Selection a. Introduction/ Background (may include literature review) b. Team c. Objective 2. Standards and Methods a. Standards & Criteria b. Methods & Audit Design c. Sample & Duration d. Data Collection 3. Compare Practice with Standards a. Data analysis b. Data interpretation c. Reason for SIQ? 4. Change Practice a. What changes implemented? b. How it is be implemented? 5. Re-audit a. Outcome b. Dissemination of findings and information c. Monitoring and surveillance d. Summary *Presentation of a Clinical Audit, should follow this format/ scheme.
CLINICPLAN Title : Department : No Recommendations Actions Required Action Dateline1 2 3 Stage * Change status 1 No action taken yet 2 In progress 3 Fully implemented 4 Action never carried out 5 Others
Clinical Audit MOH 2023 CAL AUDIT OF ACTION e Person in charge Comments/ Remarks Stage of Change*
CLINICAL AUDIT Marking Scheme 2023 CLINICAL AUDIT MOH 2023.v1 Presenter : Department/ Hospital : Title : I. TECHNICAL CONTENTS (90 marks) No . Component Marks allocation Marks Marks 1 Selection of Audit (Identify) Brief description of context/ background 20 5 What is the quality of care selected and why? 5 How it is selected (evidence)? 5 Objective 5 2 Method What are the audit criteria and standard? 20 10 Design and sample 5 Are the data collected appropriate / reliable? 5 3 Analysis and interpretation of results What were the results? 20 5 Analysis of the results 10 Reasons for shortfall in quality (SIQ) 5 4 Strategy for change What changes are needed to achieve better patient care? 20 10 How would the changes be implemented? 10 5 Monitoring (Re-audit) Outcome of implementation of change 20 15 Dissemination of information 5 Total marks I 90 II. PRESENTATION (10 marks) No. Component Marks allocation Marks Marks 1 Slides/ Videos Easily understood, appropriateness of graphics, color scheme and font size etc 5 5 2 Oral Presentation Smooth and logical flow of presentation, clarity of voice, content easily understood, keeping to time, confident and demonstrate ability of knowing subject matter well 5 5 Total marks II 10 Judge Total Marks
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