Clinical audit. What is it? Give an example an audit which would benefit your laboratory service

1. Clinical audit. What is it? Give an example an audit which would benefit your laboratory service James Polke, Institute of Neurology, London 22nd October 2009

2. Clinical Audit Definitions • Principles for Best Practice in Clinical Audit (2002): "Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the review of change. Aspects of the structure, process and outcome 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" • White Paper: Working for Patients (1989)"Audit involves improving the quality of patient care by looking at current practice and modifying it where necessary"

3. Clinical Audit in the NHS • Introduced in 1989. Used more since the late 90's as a tool to help improve accountability and public confidence in the NHS. Particularly since scandals such as the Bristol babies heart surgery deaths. • In addition, clinical audit is invaluable to ensure that treatments and services provided on the NHS are adequate and value for money. • In molecular genetics audits ensure that the tests we offer are clinically useful and accurate, that results are delivered promptly and that the service is value for money • The audit process is common sense but everyone's busy and we're human. 'Principles for Best Practice in Clinical Audit' highlights: • Creating the environment for audit • Using standard audit methods

4. The Audit Cycle/Spiral

5. Clinical Audit Workflow

6. Stage 1 – Preparing for Audit • What to audit? • Project Management and Methodology: Topic selection, planning and resources, design, feasibility • Involve relevant departments and staff, teamwork Stage 2 – Selecting Criteria • Set out the aims and objectives • Ideally: Identify local, regional or national standards that are to be achieved • If no standards exist, define some by taking into account: Research, past audits and consensus professional opinion. • Decide exactly what to measure and how to measure it

7. Stage 3 – Measure Performance • Ensure data is collected in a consistent fashion, accurately and stored in an analysable form • Ensure enough data is collected to be representative • Ensure data is collected over a long enough time period • Compare the data collected with the standards selected in Stage 2. Stage 4 – Making Improvements • Make a systematic plan to introduce changes. Include a timescale. • Communicate as clearly as possible with those affected by changes, provide support and education.

8. Stage 5 – Sustaining Improvements • Decide on a timescale before repeating the audit to assess whether the changes implemented have been successful – i.e. has the service improved as a result of the audit.

9. CPEO Audit • CPEO = Chronic Progressive External Opthalmoplegia (weakness of ocular muscles) • One symptom of some mitochondrial genetic diseases, but there are several differential diagnoses (myasthenia gravis, ocular myotosis, thyroid-associated orbitopathry, oculopharyngeal muscular dystrophy etc…) • Suspected mitochondrial CPEO patients are investigated by muscle biopsy at Queen Square, involving histology, biochemistry, and mitochondrial genetics.

10. CPEO Audit • Histology tests include staining muscle sections for: • Succinate Dehydrogenase • Cytochrome c oxidase • Biochemical tests include testing the activities of various mitochondrial respiratory-chain enzymes. • Mitochondrial genetic causes of CPEO include: • m.3243A>G (common), m.4274T>C (rare) point mutations • Large scale mitochondrial genome rearrangements • Whole mitochondrial genome sequencing • Currently it's not clear to what extent histology and biochemistry could direct genetic testing in CPEO. An audit is planned to correlate results from the three disciplines with a view to refining the genetic testing procedure.

11. CPEO Audit • Over 100 patients have had muscle biopsies, a vast majority have had histology and biochemistry performed • Many have had at least the common m.32343A>G test, and long-PCR for large scale rearrangements. • Whole mitochondrial genome sequencing has been carried out in a minority of patients. • During the audit, as many patients as possible will be tested by all three genetic methods. Genetic results will be correlated with the histology and biochemistry, also taking into account other clinical factors besides CPEO (e.g. family history, blood metabolites and non-ocular symptoms). • The aim is to identify a minimum set of symptoms and/or histology and biochemical findings that will guide which genetic tests are performed.

12. CPEO Audit • ? Audit or Research • From the RCPath website: • What is the difference between audit and research? Clinical audit: is a way of finding out whether you are doing what you should be doing by asking if you are following guidelines and applying best practice. Research: evaluates practice or compares alternative practices, with the purpose of contributing to a body of knowledge by asking what you should be doing. • The aim is to improve and rationalise service, this is in line with the aims of clinical audit

13. References • Principles for Best Practice in Clinical Audit (link to PDF): http://www.nice.org.uk/usingguidance/implementationtools/auditadvice/audit_advice.jsp?domedia=1&mid=79613703-19B9-E0B5-D4F14A0429022FC0 • RCPath Website: http://www.rcpath.org/index.asp?PageID=53 • Clinical audit support centre website: http://www.clinicalauditsupport.com/what_is_clinical_audit.html