A quality management system

1. 1. Quality - internal and external audit role of CPA (concept of a quality management system)2. Health and safety

2. A quality management system ‘The practice that encompasses all procedures and activities directed towards ensuring that a specific product it is achieved and maintained’ i.e in our labs: the right result on the right specimen from the right patient that is accurate, timely and properly interpreted.

3. A quality management system Consists of: Quality Assurance Internal quality control External quality assessment Audit

4. Quality assurance Includes monitoring of: Raw material and supplies Instruments Procedures Sample collection/transport/storage/processing Record keeping Calibration and maintenance of equipment Quality control (internal and external)‏ Staff training and proficiency Health and safety Anything and everything else…..

5. Internal quality procedures General The laboratory must be kept clean. All procedures must be carried out in designated areas, using appropriate equipment and personal protective clothing. All procedures must be carried out according to specific protocols relating to each type of analysis. All checking procedures must be signed and dated. Batch numbers of all reagents must be recorded. Sample reception All paperwork accompanying the sample must be checked for concordance with identifying information on the tube(s). Check paperwork for consent for analysis. For sample referrals with incomplete information, or sample referrals from new locations/clinicians, document details and advise the office manager who will take the appropriate action. Samples requiring urgent analysis (predictive and prenatal samples, and samples for which there is an urgent clinical requirement) must be prioritised. Samples must be stored in the appropriate location at all times. DNA Extraction Check the patient identifiers on blood and DNA tubes. Check all tube transfers. Check quality of DNA on agarose gel and Nanodrop.

6. Internal quality procedures Sample referral to other laboratories Check concordance with identifiers on the sample tube and accompanying paperwork. Check all tube transfers. Transfer of DNA using automated extractor Check the position of DNA samples before starting the equipment and have positions witnessed and signed after procedure. PCR Check all tube transfers against laboratory worksheets. All PCRs must be carried out using positive and negative controls as specified on the laboratory procedures. All PCRs must include water controls positioned on the run to allow orientation of the samples. Check PCR products on agarose gels using size standards if specified in laboratory procedures. Agarose Gels Check gel loadings as required. Results that are reported from the agarose gel must be validated, checked and signed from the gel imaging system

7. Internal quality procedures Result validation and interpretation Results should be analysed immediately after carrying out the analysis or as soon as practically possible. Each member of staff should record the results and interpretation of their own analysis before passing on for checking and determine which analyses require repeat analysis. Repeat analyses must be carried out as soon as possible. It is the responsibility staff carrying out the analysis to ensure laboratory data is checked and validated as soon as possible. Results of laboratory analysis must be checked independently. Interpretation of laboratory results must be checked independently. Any result that is novel/unusual should be discussed with a senior member of staff and if appropriate at laboratory/training meetings

8. External quality assessment Laboratory to participate in relevant external quality assessment schemes UK NEQAS, EMQN Measures labs genotyping & interpretation accuracy and report writing Can identify poor performers and remedial action can be taken Promotes best practice meetings for disorders to harmonise testing, interpretation and reporting between centres

9. Auditing Audits can be performed on any work related procedure or other to identify any problems May identify differences in practice which need to be reflected in SOPs May identify frequent errors being made in a certain task May identify deficiencies in staff training Different types of audit Horizontal Vertical

10. Benefits of a quality management system User confidence Transparency Consistency Improvement Control Protection against legal action ACCREDITATION

11. Accreditation ‘procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks’ (CPA website). Required for government for practice. Quality management system must be in place and functioning for a lab to gain CPA accreditation. Accreditation: • means that laboratories have been assessed against internationally recognised standards to demonstrate their competence, impartiality and performance capability • allows laboratories to show to its customer that it has been successful at meeting the requirements of international accreditation standards • means that the customer reduces the risk of selecting an incompetent evaluator and paying for, or more seriously, acting upon invalid results.

12. CPA CPA provides a means to accredit: • Clinical Pathology Services • External Quality Assessment Schemes (EQA)‏ Accreditation involves: • the external assessment of the medical laboratory to assess compliance with the published standards • ensuring that the medical laboratory provides a service that meets the agreed needs and requirements of its users • CPA provides a means by which this can be achieved for medical laboratories • it is a peer-review based system for the accreditation of medical laboratories in the public and independent health care sectors.

13. CPA Standards The standards are presented in eight sections: • A Organisation and quality management system • Looks at way lab is managed and organised in relation to the needs and requirements of the users • B Personnel • Staff are the single most important asset but must contribute fully and effectively to the service, while receiving fair and consistent treatment • C Premises and environment • There must be sufficient space to ensure that work is performed safely and efficiently. • D Equipment, information systems and materials • There must be proper management of equipment, data and information required to provide a service

14. CPA Standards • E Pre examination process Departmental policies, procedures and repertoire should be provided in a readable and manageable form • F Examination process • Examination procedures need to be clear, appropriate and subject to regular evaluation • G Post examination phase • The lab is to produce the results of examinations in reports that are correct, timely and unambiguous and clinically useful. • H Evaluation and quality assurance • Ongoing evaluation and improvement processes are essential to ensure that the laboratory meets the needs and requirements of the users

15. Resultant findings A non-compliance is defined as ‘the failure to fulfil the requirements of a standard, in whole or in part’. • A critical non-compliance is the ‘failure to fulfil the requirements of a CPA Standard to such a degree that, in the opinion of the assessor, there is evidence of a system failure’. • A non-critical non-compliance is the‘ failure to fulfil the requirements of a CPA Standard at a level that would not lead to a system failure’. Some findings are recorded as observations that ‘are records of deficiencies noted by assessors, that have the potential to affect the future functioning of the medical laboratory The laboratory will be visited on a two-yearly cycle alternating between a main assessment and a one-day surveillance visit. CPA reserves the right to enter and assess any previously assessed laboratory at any time and without notice.

16. Categorisation of all medical laboratories The four main categories used externally are described below: • ACCREDITED Accreditation is granted, after assessment, when there is full compliance with all CPA standards. A certificate of accreditation is provided. • CONDITIONAL APPROVAL Non-compliances have been recorded. These must be corrected within a given timescale for accreditation to be granted. • AWAITING ASSESSMENT The application for accreditation and quality manual have been accepted by CPA and the applicant laboratory is waiting for on site assessment. • NON - ACCREDITED The applicant medical laboratory is not currently accredited, conditionally approved or awaiting assessment with CPA

17. Standardisation between labs Quality improvement on national basis National Genetics reference labs Wessex; positive controls, validation of methodology Manchester; informatics (diagnostic SNP database, diagnostic mutation database)‏ Best practice meetings Promoted and organised by CMGS, EMQN Can be disease specific (BRCA, FraX, QFPCR) or general (reporting unclassified variants)‏

18. Health and safety Objectives: Maintain a healthy and safe working environment Comply with the requirements of relevant legislation Identify hazards and control risks Ensure that everyone receives appropriate instruction, training & supervision Consult with employees on H&S matters Safeguard the environment

19. Key elements of health and safety management Written policy Organisation to put H&S policies into effective practice Planning and systematic approach to implementation in order to minimise risks Measurement of performance against pre-determined standards Review of performance Audit

20. Effective H&S policies Support human resource development Minimise avoidable unplanned events Recognise that accidents, ill health etc result from failings in management & are not just the fault of individual employees Ensure a systematic approach to the identification of risks and allocate resources to control them Support quality initiatives aimed at continuous improvement

21. Training for H&S Decide if training is necessary Identify training needs Identify training objectives Develop learning activities Carry out training Evaluate effectiveness

22. Obligations of individuals To act in such a manner as to preserve the H&S of themselves and others (eg. Protective equipment etc)‏ To learn and implement agreed safety policies and procedures Notify relevant people of any matter which appears to suggest a potential H&S hazard Not to interfere with or misuse anything provided in the interests of H&S at work

23. Health and safety documents Departmental H&S policy Radiation safety policy (if relevant)‏ COSHH documentation Risk assessments Waste disposal policy Incident report documents Fire regulations All documents should be all be accessible and staff should know location

24. Key areas of H&S Biological safety Sample reception, handling and transfer btn areas Problem samples (leaking tubes/stained forms)‏ Hep B&C and HIV risk and routes of infection (vapours, splashing, sharps etc)‏ Chemical safety Hazard data sheets Use and storage of minimum quantities Separation of corrosive, flammable and toxic chemicals Isolate storage areas Training and SOPs Use of protective equipment Storage and disposal of waste Action in case of spills Minimising usage of hazardous chemicals eg kits

25. Key areas of H&S Radiochemical safety Ionising radiation regulation and local rules Only used when there is net benefit and no reasonable alternative Exposure should be as slow as reasonable possible and never exceed recommended limits Radiation protection supervisor Disposal procedures (even when off the premises – lab is responsible Records – reception, storage usage, waste storage and disposal and monitoring procedures Decontamination procedures Fire safety Raising the alarm/sound of fire alarm Location of fire exits Types of extinguishers and locations Ensuring areas are clear Assisting with patients Meeting points

26. Key areas of H&S Waste disposal General non-hazardous waste Biological waste Sharps/Glassware Material for autoclaving before disposal Radioactive waste Labelling of waste Who deals with waste afterwards eg. Porter etc

27. Key areas of H&S Spillages/accidents/injuries Know locations of spill kits, first aid kits, eyewashes etc Clearing up spillages and disposal of the waste Injury – eyes, mucous membranes, puncture injuries, cuts, electric shock etc Departmental first aider Possible infection – medical advice, retain offending items Reporting of incidents and completion of accident report forms First aid One’s own safety Summoning aid Departmental first aiders ABC of first aid Reassurance of shocked patient Medical assistance Reporting of incidents