1. Describe the core processes and principles of quality management

1. Laboratory Management Thursday 22nd October 2009 MAI M ABD EL-AZIZ 1. Describe the core processes and principles of quality management

2. Quality Management (QM) • A system that provides organizations with • Structured method of recording 'best practice‘ • Planned means of achieving continual improvements • Through the setting of objectives and targets • Is considered to have three components • QC is used to ensure that services are designed and produced to meet or exceed customer requirements. • QA is planned and systematic production processes providing confidence in a product's suitability for its intended purpose. • QI covers product improvement, process improvement and people based improvement.

3. International organization standards (ISO) definition of QM • “QM is that aspect of the overall management functions that determines and implements the quality policy This means that • Commitment and participation of all members of the organisation is required to attain the desired quality. + 2. QM includes strategic planning, allocation of resources, quality planning, operations and evaluations. Achievement of successful QM

4. QM & Accreditation • Accreditation is a procedure by which an authoritative body gives formal recognition that a body or person is competent to carryout specific tasks. • ISO contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent and are able to generate technically valid results.

5. The process of quality • Can be divided into 4 important phases according to W.E Deming (American statistician) Phase 1: Plan Phase 2: Do Phase 3: Check Phase 4: Act • A 5th phase is to develop new plans before going into the following processes and hence QM is a process of continuous improvement.

6. Principles of QM • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

7. QM in CMGL QM will ensure that the service provided by the CMGL is ACCURATE & is of HIGH QUALITY. The demand for molecular genetic testing has enormously increased in the last few decades. Since the results of DNA diagnostic testing can have a major impact on clinical decision- making.

8. Quality in a molecular genetic lab can include any of the following • Reporting times • Written reports • Training • Facilities/equipment/supplies/waste management etc. • All CPA standards • Can be disease specific (BRCA, FraX, QFPCR) or general (reporting unclassified variants)

9. Management functions (1) • The managerial and technical personnel of the organisation should have the authority and resources needed to carry out their duties. • Job description should be regularly updated to reinforce the staff’s duties and responsibilities within the lab. • Documented training procedures should be in place. • The results and their interpretation should be authorised by an independently qualified person who is different from the scientist who carried out the test. • A fully interpretive report on the results has to be forwarded to the referring clinician by the scientific staff.

10. Management functions (2) 6. There is a continuous need of additional extra well trained personnel this owing to the increased demand of genetic tests. 7. Laboratory management has to ensure that there are clear criteria of who can perform a second independent check of data. 8. Laboratory management has to appoint laboratory quality managers with defined roles and responsibilities and have the authority to implement them 9. The quality manger should be independent but has to report to laboratory management and participate in laboratory policy and resource decision-making process.

11. Sections of CPA revised standards Burnett et al., 2002

12. Internal factors External factors Core processes in QM • Can be viewed as factors that might affect the quality of work Reagents Equipments Staff Finances Procedures Pressure

13. Internal factors (1) • Work procedures: 1. The receipt of the sample Sample mix up, sample contamination, sample lose ….. • Sample labelling(at least 2 unique IDs, print labels, minimise hand writing and 2nd person to check label info vs. request info and sign) • Request form(should be suitable and correctly filled) • Sample storage (duplicate storage of blood/DNA/blood spots/proper storage of DNA) • Backup of data(serial back up of data on password protected computers

14. Internal factors (2) • Work procedures: 2. DNA extraction • Extraction should be performed in dedicated areas • Performed by trained staff • Sample transfers witnessed& signed off by 2nd ID • Automated if possible • Patient’s info and reagent detail in work sheets • Work should be dated and signed by an operator

15. Internal factors (3) • Work procedures: 3. PCRing • Dedicated areas for set up • Dedicated pipettes used • Suitably trained staff to perform the work • Appropriate controls used (no template, positive/negative Cs) • Worksheets generated e patient and reagent details • Operator to sign off and date work • Sample transfers checked and signed off • Level of acceptable result? (Pass or fail) • Results recorded and stored

16. Internal factors (4) • Work procedures: 4. Use of controls First line controls • Negative controls (with no mutations) • No template controls (to check for contamination) • Molecular weight seizing (to check correct size product or digest ) Second line controls • Setting up duplicate DNA samples in two separate rounds in order to check for the method of DNA extraction. • Positive controls which means including samples that have a mutation in the tested gene. (CRM) • Testing the segregation of a change in all family members • Using immortal sources of DNA samples such as the lymphoblastoid cell lines and the CEPH as a reference for haplotyping.

17. Internal factors (5) • Work procedures: 4. Use of controls Third line controls • Laboratories can check their performance, results and quality controls by participating in organised External Quality Assessment (EQA) schemes for MG. • Examples of these are: EMQN (European Molecular genetic Quality Network), UKNEQAS (United Kingdom National External Quality Assessment Scheme) for molecular genetics, ECFTN (European Cystic Fibrosis Thematic Network). • The performance of a laboratory is evaluated by its ability to correctly perform genotyping of DNA samples against a mock clinical question and provide a full interpretation of the results.

18. Internal factors (6) • Work procedures: 5. Validation of methodology by ensuring that it is robust, sensitive and specific. • Reagents: • Set up database of reagents ordered including the batch numbers, date received and their expiry. • Commercially available versus in-house make.

19. Internal factors (7) • Equipments: • A suitable equipment to do the job • Record number of equipments • Service contract • Routine maintenance • Electrical safety • Recording of faults, errors and breakdowns.

20. External factors (1) • Staff: 1. Professional attribute • Appropriately trained (HPC registered) • Continuously develop (professional training) • Properly supervised • Within an organisational structure 2. Personal attribute • Good communication skills are essential as team player, report problem and for praising. • Well being of the staff within the post is critical so staff should feel valued, not be overloaded by work, can manage workload, appraised in place, satisfied by the job (enough rotations, new methodologies, new responsibilities), aware of pressure of deadlines.

21. External factors (2) • Finance:is among the important factors that can affect the quality of work since limited resources can hinder a good quality work. Enough resources will allow • Buying high quality reagents • Adherence to the expiry date on the kits • Buying enough equipments • Maintenance of the equipment (Service) • Travel expenses to go to conferences • Enough budget for training of the personnel

22. External factors (3) • Pressure: • Avoid increasing pressure with increasing workloads • Minimize pressure by managing workload • Specific tasks at certain times to avoid distractions • External pressures- (be aware of personal issues and manage staff accordingly).

23. Auditing • Audits can be performed on any work related procedure to identify work related problems • May identify differences in practice • May identify frequent errors being made in a certain task • May identify deficiencies in staff training

24. What are the benefits of quality management system?? • To seek accreditation • For private-sector laboratories the benefit is directly commercial since an accredited for the service will attract more clients. • For public-sector laboratories the benefit is mainly for the laboratory and its users. • So in case of CDMGLs the benefit is for both the referring clinician and the patient and it will begin from receiving the blood sample to the communication of the results in the form of a written report.