Session 7 - Quality and Lab Management Flashcards
What is the definition of “Audit”
A systematic, documented and independent process to obtain evidence and objectively evaluate the extent to which a set of criteria are fulfilled.
What are the 5 stages of the audit cycle?
Set standards Measure current practice Compare practice vs standards Reflect, plan, implement change Re-audit
What are the purposes of audit?
To demonstrate quality of service Identify areas for change Continued improvement Assist in implementation of guidelines and services Monitor consistency of performance Measure performance against benchmark
Name the 4 classes of Audit.
- Clinical audit
- Horizontal Audit
- Vertical Audit
- Examination audit
Describe the 4 classes of audit and give an example of each
Clinical audits - they form part of clinical governance, they are required to provide evidence of current practice against national guidelines and monitor patient outcomes. They can be prospective or retrospective. e.g. referral patterns or TATs
Vertical audits - allow audit of an entire workflow/process. Used in labs to follow one sample from receipt to report - record everything (temperature of fridges, lot numbers, staff training records etc.)
Horizontal audits - examine one part of the process in detail. Can be used to determine if all batch records are held in the right place.
Examination audits - Witness to see if a SOP is being correctly followed, or staff members are appropriately trained.
What should be contained within an audit record?
Name of staff member performing the audit Date performed Reference number The scope of the audit Any non-conformaties Any CAPAs Date and signature on completion
What is a Quality Management System?
A defined set of procedures, structures, regulations and responsibilities that ensure the organisation is capable of delivering required standard of services
What are the benefits of a QMS?
Improve and monitor lab performance
Achieve better control of processes
Safeguard the organisation, public and staff
Ensure minimum standard quality service for patients
Ensure the lab is managed efficiently and effectively to meet users’ needs
Provides a framework for staff to ensure good quality service
To ensure all labs have standard sets of practices with common goals
Achieve accreditation
What are the 9 components of the QMS?
Quality manual QMS documentation Quality Assurance - getting it right first time Internal QC Quality Improvement Continual Improvement cycle Quality Assessment Audit Accreditation
Give examples of QMS documentation
Quality Manual Policies Calibration certificates COSHH forms SOPs H&S records Meeting minutes Job descriptions and staff records Staff training records and CPD Appraisal records Maintenance records Batch records Incident forms Audit records Verification/Validation records Test results/reports
How does a QMS stop errors occurring?
Ensures all aspects of a process are considered
Documents procedures to ensure standards are met
Encourages review of techniques to ensure up-to-date methods are used
Controls SOP changes
Provides platform for continuous improvement
What does UKAS value, in terms of quality improvement?
PRIDE: Professionalism Responsibility Innovation Delivery Excellence
What are CAPA?
Corrective and Preventative actions.
Corrective actions eliminate the cause of the non-conformity
Preventative actions stop a potential non-conformity
Outline the Continuous Improvement Cycle
Plan (determine user requirements and plan how these will be met)
Do (acquire resources to meet requirements, document procedures, provide traiinng, implement working procedure)
Check (audit to ensure activities are carried out correctly)
Act (correct and prevent when things go wrong)
List standards applicable to a diagnostic laboratory
ISO - ISO15189:2012 (medical laboratories) CPA standards (superseded by ISO) HCPC standards for staff Professional BPGs UKNEQAS codes of practice, EMQN, WEQAS... NHS standards, NICE guidelines Human Tissue Act (2004) EuroMRD (new MRD test for haemonc)
What is the role of UKAS?
UKAS is the sole national body responsible for assessing labs against the internationally agreed standards.
What are ILAC and IAF? What do they do?
ILAC is the International Laboratory Accreditation Cooporation
IAF is the International Accreditation Forum.
They work together to ensure that accreditation body members (such as UKAS) only accredit bodies that are competent to do their work.
What do the UKAS standards 15189:2012 cover?
Equipment Reagents Staffing Documentation - SOPs and document control Premises Validation of test and services Quality management QA CAPAs and non-conformity records
What are the three stages of UKAS assessment?
Pre-assessment
On-site assessment
Post-assessment monitoring/surveillance/re-assessment
What are the potential outcomes of a UKAS inspection?
Immediate accreditation - no action needed
Accreditation offered, subject to satisfactory improvements by the lab
Accreditation for a reduced schedule - if lab fails to demonstrate competence in one or more areas
Accreditation refused - discuss with UKAS
List some EQA schemes currently available to UK genetics labs
NEQAS
CEQAS
EMQN
EuroMRD
How are NEQAS results scored?
Each criteria marked out of 2.0:
genotyping
interpretation
clerical accuracy
What is indicative of a poor performer in the NEQAS scheme?
Mean genotyping score <1.6
Mean interpretation score <0.7x the mean score of all labs
What is the process undertaken if lab are identified as a poor performer?
Genotyping: participant notified and given a defined timescale in which to respond. Extra round of EQA supplied - if performance satisfactory, poor performer status removed.
Interpretation: Possible extra round of EQA, most likely remains PP until next round of EQA
What happens if a lab is identified as a persistent poor performer?
Persistent PP classed as poor performance for a disease in 3 out of ANY consecutive 6 rounds OR poor performer in 2 consecutive rounds
Remedial action defined by NQAAP panel, possible contact of regulatory body - UKAS/CPA. Give advice to head of lab.
How is persistent poor performance defined in the CEQAS scheme?
2 poor performances over three distributions of material within a 36 month period
1 poor performance within 1 year of a previous persistent PP
Summarise the changes between ISO standard and previous CPA standards.
Updated clauses Measurements of uncertainty Staff competence Validation/verification Purchasing Traceability Lab director responsibilities EQA/IQC
New clauses: Evaluation and risk management Staff suggestions Information management Equipment records Service agreements
Define Validation
The process by which performance specification, accuracy and limitations are defined. Results compared against controls and known standards.
Define verification
The comparison of a modified performance specification with an existing specification.
What are the 15 considerations to be taken into account when deciding on whether to introduce a new test into the laboratory?
- Is there a clinical need for the test? - # of samples, disease incidence etc.
- Is there a clinical demand for the test? - who will order the test, where would referrals come from?
- Does the test have clinical utility? - would results affect treatment or health outcome, low penetrance, environmental effect?
- Is the test ethical/legal?
- Technical testing strategy - what type of test? what sample type? mutation types? Accuracy, reliability, sensitivity/specificity etc. Screen or diagnostic?
- Impact on current working practices - potential workload, staffing, set-up time
- Will the new test replace an existing test? - improve TAT? improve DxYx, how much DNA/cells needed? controls needed? externally or internally validated test? confirmation of results?
- Budget considerations - staffing, consumables, equipment, competitive pricing, need a business case? NCG funded test?
- Implications for staffing and training requirements
- Equipment/lab set-up - which techniques are best, new or existing equipment?
- Population factors
- Background work - disease information etc
- Validation work - including SOP writing, audits, enrol in EQA scheme
- Implement service - training other staff, ongoing improvements, authorise SOP, worksheets and information management, report templates, advertise service, gene dossier?
- Request user feedback once test established - user surveys
What is the role of UKGTN?
It is an advisory body which provides information about genetic testing services to support commissioning of services.
What functions does UKGTN fulfil?
Identify lab services Lab membership - need to meet criteria (accreditation etc) Evaluate new tests Oversee a transparent process Offer an online test directory Influence national policy
What is the UKGTN CSAG?
Clinical and Scientific advisory group.
Made up of 4 working groups: Genetic test evaluation group (receives gene dossiers) Lab membership and audit Development working group Rare disease service improvement group
What is the purpose of a UKGTN gene dossier?
Set of 44 questions to provide comprehensive information for the genetic test evaluation working group. Covers reasoning behind offering the test
What criteria are used in the UKGTN’s assessment of tests? Describe the framework
The ACCE framework. Analytical validity Clinical validity (PPV and sensitivity/specifcity) Clinical utility Ethical, legal and social
What is the ~ equivalent of the UKGTN in the USA?
The CDC established the EGAPP in 2004 to offer the same service as the UKGTN in the UK.
What is the role of NICE in genetic testing?
Producing evidence based guidelines
Develop quality standards of care and testing, and performance metrics
Provide information to commissioners and practitioners
Give some examples of NICE’s role in genetic testing
CG128:Autism - discusses use of aCGH
NG14: Melanoma - discusses use of genetic testing
Developed quality standards for Breast Cancer
Technology appraisal: TA34 for Trastuzumab for the treatment of Her2+ tumours
Diagnostics and Medical Technologies Evaluation Programme - evaluates new diagnostics and technologies for NHS use
Define clinical governance
Clinical governance is a system through which NHS organisations are responsible and accountable improving quality of their services and safeguarding high standards of care.
What are the three key attributes of clinical governance?
- recognisably high standards of care
- Accountability and responsibility for those standards of care
- Constant improvement
List some components of clinical governance
Clinical audit Clinical effectiveness Education and training Risk management Openness R&D Clinical information and IT Patient and public involvement Staffing
Which organisations produce Clinical Governance guidelines that should be followed by members of the UKGTN?
BSGM
Genetic Alliance Group
Define Risk
The potential that an action or inaction will result in an adverse outcome.
How can risk be managed?
Identify what can go wrong
Understand what causes things to go wrong
Learning lessons from adverse effects
Ensuring action is taken to precent recurrence
Put measures in place to reduce risk.
What should be considered the most effective way to reduce risk?
Staff training
Give some examples of risks in the lab
Sample mix-up Hazardous chemical usage Manual handling Incorrect information on report Streamlining services to cut budget / staff shortages Introduction of a new a technology Needlestick injury
