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!)