Development and Implementation of a Quality System The Molecular Diagnostics Research Laboratory University of Malaya

1. Development and Implementation of a Quality System The Molecular Diagnostics Research LaboratoryUniversity of Malaya Yap SF Department of Pathology University of Malaya

2. Backbone of the Accreditation Process Standards of Laboratory Practice Criteria against which all laboratories are judged

3. Requirements for Laboratory AccreditationCAP Checklist 1992 • Planned and systemic QAP • QAP in effect at sectional level • Documentation, monitoring, evaluation of QA indicators in each section at all shifts • Monitoring & evaluation efforts documented, reported with appropriate actions • Annual internal appraisal of QAP to assess all elements of the QAP • Laboratory director and all professional staff must participate in the QA activities

4. Standards and GuidelinesCPA A set of 6 standards (A-F) • Organisation and administration • Staffing and direction • Facilities and equipment • Policies and procedures • Staff development and education • Evaluation

5. Standards and GuidelinesISO/IEC 17025 • “General requirements for competence of testing and calibration laboratories” • Released 2/2000 • Replaces ISO/IEC guide 25 • Encompasses : “Management System Requirements” “Technical Requirements” • Internationally recognised basic document for accreditation of laboratories

6. Structure of ISO/IEC 17025 Section 1 : Organisation and Management Section 2 : Technical Requirements New Elements : Control of non-conforming tests Measurement of uncertainty Verification of standard methods Plan for introduction of analytical methods ISO 9000 like Quality Management

7. Key Elements of ISO/IEC 17025 • Internal QC • Participation in external QAS • Working procedures or Standard Operating Procedures (SOPs) • Use of traceable standard reference materials • Instrument maintenance and calibration • Validated methods • Report of measurement uncertainty • Qualified personnel • Records and reports

8. Standards and GuidelinesISO/DIS 15189 • “Quality Management in the Medical Laboratory” • Drafted by technical committee ISO/TC 212 • For clinical laboratory testing • Provides requirements relevant to “quality management” of medical laboratories • Encompasses : “Management System Requirements” “Resources and Technical Requirements”

9. Guideline on Development of a Quality SystemNCCLS doc GP26A • A quality system model for healthcare • Consistent with requirements of the ISO guide for quality standards • Applicable to any service in a healthcare organisation • Based on the application of a list of quality system essentials (QSE) applied to ALL operations in the workflow path

10. Quality System Elements Organisation Personnel Equipment Process Control Documents and Records Purchase and Inventory Internal Assessment Process Improvement Occurrence Management Service and Satisfaction

11. Quality System Management Requirements • A Management Policy and System • Standardisation of Procedures • Documentation of : - Quality Policies - Management Procedures - Operational Procedures • Internal Audits • External Assessment

12. Implementation The Initial Phase 1. Development of a quality manual(QSE : Organisation) 2.Development of Process Control(QSE : Process Control) a) Analysis and validation of processes b) Development of SOPs c) Implementation of process control checks 3. Development of a management system for documents & records(QSE : Document Control)

13. Development of Processes and Procedures 1. Staff training & competence testing(QSE : Personnel) 2. Equipment management(QSE : Equipment) 3. Purchase and inventory(QSE : Purchase and inventory) 4. Control of non-conforming product(QSE : Occurrence Management) 5. Internal quality indicators and audit(QSE : Internal Assessment) 6. Process improvement(QSE : Process Improvement) 7. Monitoring of service & customer satisfaction(QSE : Service and Satisfaction)

14. Development of Process Controls 1. Process analysis 2. Process validation 3. Preparation of SOPs 4. Implementation of process controls QC programme PT programme Occurrence log Development & use of quality indicators

15. Equipment Management Plan 1. Verification of functional status 2. Determination & documentation of schedule for service and calibration 3. Preparation of procedure manuals 4. Implementation of instrument logs 5. Prepare inventory 6. Appointment of equipment management officer

16. Personnel Orientation, Training and Education 1. Orientation of new staff 2. Initial instruction & training Laboratory safety General laboratory procedures Quality laboratory practices 3. Continuous education and competence monitoring 4. Documentation of training and education

17. People Qualification • Analytical Technique • Instrument Operation • Result Interpretation • Basic Troubleshooting • Regulations and Quality Standard Requirements

18. The 10 Step Implementation PlanWhere are we? • Develop & implement quality system • Develop SOPs • Develop organisation infrastructure (including roles and responsibilities) • Train people • Validate equipment • Validate analytical procedures • Develop program to use certified reference materials • Develop quality assessment schemes • Develop internal audit program • Develop procedures for recording & archiving

19. What is Quality? A word widely used and apparently well-understood but seldom defined Crosby “ Quality has much in common with sex” Everyone is for it(Under certain conditions, of course) Everyone feels they understand it(Even though they wouldn’t want to explain it) Everyone thinks execution is only a matter of following natural inclination(After all, we do get along somehow) And of course most people feel that all problems in these areas are caused by other people(If only they would take time to do things right)

20. Quality Laboratory Processes (QLP) and Quality Control (QC) • QLP: Good processes, procedures and people • QC: Control of products and processes • QLPandQCcan be grouped into 3 areas : Pre-analytical Analytical Post-analytical

21. Quality Requirements The Medical Laboratory Perspective • Staff– qualification, training, experience and competence • Facilities – adequate and appropriate • Test menu– repertoire, medical usefulness • Support– specimen acquisition, transportation, processing, storage • Analysis– appropriate analytical quality • Service– fit demand for use, meet needs for TAT • Communication– mechanism effective

22. A Comprehensive QAP for the Clinical Laboratory • Design control : facility, staffing, analysis • Raw material control : standards, controls, reagents, instruments and equipments, samples, personnel • Process control : internal (calibrate and control processes)& external (monitor proficiency) • Output control: result and medical significance • Reliability control: test utilisation and patient needs/outcome • Verification control: inspection, accreditation, productivity, cost analysis

23. Quality System Elements • (Standard) Operating Procedures • Method validation • Instrument validation, calibration, maintenance • Documentation of tasks and procedures • Personnel qualification • Use of qualified reference material • Internal audits • Records

24. Accreditation Bodies • College of Pathologists (CAP) LAP, USA • Joint Commission on Accreditation of Hospitals (JCAHO), USA • Clinical Pathology Accreditation (CPA), UK Ltd • National Association of Testing Authorities (NATA), Australia • Department of Standards (DSM) Malaysia – “SAMM”