King’s College London

1. King’s College London

2. King’s College Hospital 2014

3. Purpose and Practice of Audit Dr Munther J Hussain King’s College Hospital, London

4. Introduction • Medical laboratories are the key partners in patient safety • Laboratory results influence 70% of medical diagnoses. • Quality of laboratory service is the major factor which directly affects the quality of health care

5. Pathology Department Accreditation • In the UK, pathology department accreditation is carried out by an independent non-profit making company known as CPA (Clinical Pathology Accreditation) • Accreditation is an external audit of an applicant department’s organization and quality assurance program. • The CPA (Clinical Pathology Accreditation Ltd) defines standards ((ظوابط for organization and performance of clinical pathology. • CPA inspectors will usually visit each department in pairs, each team consisting of a consultant or clinical scientist and a senior MLSO

6. Accreditation Standards ( 8 Standards) المختبر ونظام السيطرة النوعية العاملين بناية المختبر تقييم النتائج أدوات المختبر أجراءات قبل وأثناء و بعد الفحص المختبري

8. What are Audits? • ISO19011:2002 –“a systematic, independent and documented process for obtaining audit evidence and evaluating it objectivelyto determine the extent to which audit criteria are fulfilled” –a way to establish whether all activities that affect quality are being carried out competently

9. ISO ISO has developed over 17500 International Standards on a variety of subjects and some 1100 new ISO standards are published every year ISO 15189 (2007) specifies requirements for quality and competence particular to medical laboratories

10. ISO (International Organization for standardization) ISO is the world's largest developer and publisher of International Standards.

11. What is the purpose of audit? •To assess compliance with laboratory polices and procedures •To assess and verify compliance with external standards •To determine effectiveness of your quality management system •To identify areas of possible improvement

12. Lesson No. 1! An audit is not a tick box exercise to satisfy CPA It is a tool for identifying and facilitating improvement

13. Type of Audit? Internal/External Horizontal/Vertical Audit: Examination process to check list compiled from the quality system manual e.g. Policies, Staff development, Lab Manuals, , Safety policies, Equipment maintains Horizontal audit: To examine one element in a process (staff development) on more than one item (how many people have had a training course in one department)

14. What type’s of audit are there?

15. What are the benefits of Internal Audit? •Identifies weaknesses before they become actual failures • • Gives the auditee confidence in the system •Means of maintaining and improving the system •Shows staff that management take quality seriously by resourcing auditing and reacting to problems found •Provides evidence of due diligence

18. What are the limitations of audit? • Audits are a sampling exercise. • Audits cannot confirm that all aspects of the quality system are being complied with at all times. •One part of the assurance system

19. How to establish the Audit Programme? • Objectives and Extent • • Responsibilities • • Resources • • Procedures

20. How to implement the audit Programme? •Schedule the audits المراحل •Evaluate the auditors تقييم المدقق •Select audit teams •Direct auditing activities •Maintain Records

21. How to monitor and Review the Audit Programme? • Ability to implement audit plan • Compliance with audit procedure • Identifying need for corrective actions • Non-compliance/RCA trends • Feedback from auditees • Quality improvement notes

26. Lesson No. 2 •Audit the system, not the staff •If someone is doing something wrong it is usually the system which is at fault, not the person –Have they been properly educated, instructed & trained –Is the prescribed method wrong? –Has the line manager monitored their work sufficiently to pick up errors

27. CPA Standards Quality Assurance, QA Quality Control, QC Assessment Internal/external Audit Vertical/horizontal Medical Lab Accreditation

28. Quality Control - QC refers to the measures that must be included during each assay to verify that the test is working properly. Quality Assurance - QA is defined as the overall program that ensures that the final results reported by the laboratory are correct Quality Assessment - is a means to determine the quality of the results generated by the laboratory. Quality assessment is a challenge to the effectiveness of the QA and QC programs.

29. Quality Assessment Quality assessment is a means to determine the quality of results. External quality assessment (EQA) is now recognized as an essential component of quality assurance and is the only means to give the laboratory manager an independent means of ensuring that his routine quality control is adequate and effective.

30. Quality Assurance QA is an ongoing process that requires daily attention by all laboratory staff. Some fundamental issues in QA related to specimens include; 1-Inspection of all specimens upon receipt and before testing to ensure that they are suitable, Lipaemic, haemolysed or 2-contaminated samples should not be used as these may interfere with assay performance. 3-Patient information should be available on the tube 4-If the serum sample is frozen before testing, the sample must be well mixed after thawing and before testing. 5-All test results, controls and records must be checked and rechecked to ensure that the proper specimen was resulted before reporting.

31. Last Lesson "The aim of quality control is simply to ensure that the results generated by the test are correct. However, quality assurance is concerned with much more: that the right test is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time" • Many variables can affect the quality of results • The educational background and training of the laboratory personnel • The condition of the specimens • The controls used in the test runs • The interpretation of the results • The transcription of results • The reporting of results

32. CPA Standards Quality Assurance, QA Quality Control, QC Assessment Internal/external Audit Vertical/horizontal Medical Lab Accreditation Thank you for listening

33. CPA Standards Quality Assurance, QA Quality Control, QC Assessment Internal/external Audit Vertical/horizontal Medical Lab Accreditation Thank you for listening