CMGS Clinical ScientistTrainees Meeting 28th November 2009
QUALITY ISSUES
IQC, EQA, CPA
Gareth Cross
Nottingham Regional Molecular Genetics Service
Quality Issues
• Is a laboratory providing a good service?• Who wants to know?
– = those responsible• Manager• Trust• Commissioners• DH• People using the service – doctors, patients
– You !
Quality?
• Doing the right tests
• Interpreting the test results correctly
• Reporting the results – to answer the clinical question – so that the clinician can understand them– in a “timely fashion”
• Not mixing up the samples etc.
How?
• Correct tests, interpretation, reporting?– Training– Qualifications , 2 year CS training, registration, FRCPath– Above= appropriate for position
• Agrees with peers– Best practice guidelines– External Quality Assurance (EQA) scheme
• Internal Quality Control– Tube transfer checks– Bar-coding– Result and report checking
EMQN - Draft Best Practice Guidelines for Laboratory Internal Quality Control – Patton and Stenhouse
CMGS – Practice Guidelines for Internal Quality Control within the Molecular Genetics Laboratory
• Via CMGS website• Sample reception
– Secure database, backed up– Checking x transfer data– Incomplete data– 2 unique identifiers – name,DOB, barcode, H No.– Printed labels – Reduce data transfer– Audit trail x information change– Minimise hand written transfer information
Internal Quality Control
• Sample storage– Stop DNA decay
– Duplicate back up x DNA or blood
– 2 pieces info on DNA tube labels
• DNA extraction– Dedicated areas and pipettes to reduce contamination
risk
– Reduce tube to tube transfers – automation
– Decide on optimum batch size
Internal Quality Control
• Sample Handling– All tube transfers – checked independently +evidence – or
performed in duplicate– Records of batches – troubleshooting– Separate pre and post PCR areas + pipettes
• Controls– Normals, water, +ves, molecular wt markers– EC: In-Vitro Diagnostic Devices – need CRMs
• Results– Store all raw data x 5 years minimum (RCPath: 30 years “The
retention and storage of pathological records and archives” )
Internal Quality Control
• Reporting– Checked independently – Standard wording templates?– Procedures for telephone, fax etc
• PND– Maternal contamination – CA repeats
• Test validation
External Quality Assurance
• NEQAS and EMQN• Volunteers• At least, annually for each disease, where
available• 3 DNA samples/disease + clinical story – treat as
normal • Genotype accuracy• Interpretation accuracy
EQA
• Report writing• Reassurance + educational + required by CPA• Poor performers x genotyping or interpretation
(0.7 x average)• Persistent PPs – 3/6 or consecutive 2 – per disease
- NQAAP (> JWGQA>DH) – HOD• www.ukneqas-molgen.org.uk• www.emqn.org• THESE ARE IMPORTANT TESTS TOO!
Convincing our commissioners, managers, and users?
• Accreditation against standards– Clinical Pathology Accreditation (UK) (CPA) – now owned by the
UK Accreditation Service
• Assessing v standards based on International Standards – ISO 15189
• Regional Genetic Laboratories are required to be “CPA accredited” (2003 White Paper)
• Reports to commissioners, UKGTN etc re reporting target compliance etc.
CPA accreditation
• Labs sign up to complying with 8 standards:– Organisation and Quality Management System
– Personnel
– Premises and Environment
– Equipment, IT systems and materials
– Pre-examination processes
– Examination processes
– Post-examination processes
– Evaluation and quality assurance
A:Organisation and Quality Management System
• Appropriate staff + management structure
• Quality Management System– Procedures and policies in writing and
document- controlled– Process records– Control of clinical material– User satisfaction
B: Personnel
• B1.1 Consultant equivalent in charge
• Staffing –appropriate numbers– Quality, training, health and safety managers– Annual review, job des, staff meetings etc– Induction, training
C:Premises and Environment
• Staff facilities
• Storage x records, DNAs, bloods, waste, chemicals etc.
• Health and Safety – protective equipment, fire training, COSHH assessments, scpecimen collection and handling, safety notices, cleanliness
D: Equipment, IT systems and materials
• IT – back-up, confidentiality, adequate
• Equipment is maintained:– Accurate– Breakdowns– Safe
• Materials – COSHH – date of receipt etc
E: Pre-examination processes
• User info – leaflets, web site – disease tests, samples needed, TATs etc
• Request form + adequate information x patient + test request
• Specimen reception x data collection + staff safety + rejecting specimens
• Sendaway protocol + records
F: Examination processes
• Need SOPs for all tests– Training– Clear re decisions on, e.g. numbers of controls
etc
• Need IQC procedures
G: Post-examination processes
• SOPs x reporting, telephoning, amending
• Adequate report x identification, interpretation etc.
• = managers taking responsibility for decisions
• Protects YOU
H: Evaluation and quality assurance
• User satisfaction surveys• Meet performance targets• Internal audit - checking processes by
horizontal, vertical and examination audit – i.e. is anything going wrong?
• External QA – all appropriate – communicated – staff + decisions recorded
• Quality improvement
CPA - 4 year cycle
• 4 yrs Assessment x Regional assessors + peer assessors
• 2 yrs Regional assessor• Examination audit – training, following SOPs• Interview x training, induction, IPR etc• Assessment x departmental management• Non-compliances always found• Painful but necessary (to keep funding!)