CMGS Clinical ScientistTrainees Meeting 28 th November 2009 QUALITY ISSUES IQC, EQA, CPA Gareth...

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!)