what is a contingency plan?
A management process that analyses specific potential events or emerging situations that might threaten society. These plans establish arrangements in advance to enable timely, effective, and appropriate responses to such events and situations
eg. Brexit, COVID, NICE guidelines change
what are the 3 steps to create a contingency plan?
- assess the risks
- create contingency plan (what is the risk? who is in charge? document communications, update SOPs)
- maintain contingency plan
give examples of scenarios where a contingency plan may be needed for a genomics lab?
- flood, severe weather, illness, hazardous spill, terrorism, theft, loss of equipment, loss of IT, covid, Brexit
what local mitigating actions would you take to minimise risk to genomics delivery for contingency plan? Eg. For covid
- document changes to services in quality management system
- minute meetings where decisions to staff and services are made (UKAS requirement)
- consult with service users
- how you would deal with sudden increase in numbers as clinics return
-keep staff well: social distancing at work (move desks, screens, mental health support), regular cleaning, handwash stations, face mask supplies - work out minimum staffing required at all bands
- validate alternative suppliers/reagents which are less likely to be effected
- share equipment with other labs
- allow flexible working for childcare
- NHSE - distribute resources centrally
- flexible rotas, prioritise urgent samples
- redeploy staff to urgent tests eg. prenatal
- virtual clinics
- cross-team working
- consider evening/weekend work
- arrange to divert samples if necessary
- virtual MDT meetings
- arrange business contingency planning meetings
- ask for feedback from staff
- ensure staff have necessary competencies - may require training
- raise any issues of concern on the local risk register for Trust-level awareness
- stop services with low staffing and least critical
- reduce NGS runs to accommodate lower staffing
- automation where possible
obtain bank staff, locums, retired staff - one way systems in lab
- communicate to service-users that buccal not allowed and to switch to bloods
- order consumables in good time, increase orders to ensure well-stocked
- use alternative local/national equipment and discuss if maintenance can be performed in-house
- engage with IT to highlight resources required - laptops, headsets, Teams support
- signpost staff to health and wellbeing support
how does the covid pandemic affect genomics labs?
NEGATIVES
- staff sickness and leave for isolation/childcare
- anxiety and stress
- mental health/lonliness
- furlough for staff who cannot work on site and have no work to do at home
- tensions around mask-wearing and PPE
- inequality between scientists at home and lab staff
- WFH demand, information governance, ICT, chair and desk suitability, paperless workflows, ICT support - VPN and remote access
- resources - consumables and reagents
- lack of availability of engineers
- license availability like mutation surveyor key
- engagement in remote meeting
- individual performances difficult to monitor
- lack of team ethos/social aspect
- Brexit supply chain compounding issue
- sample reductions - but may have sudden influx and urgent patients may present late or more accutely
- disruption to UKAS inspection, EQA and conferences
- infectious samples - need risk assessments
POSITIVES
- boost to genomics profile due to covid genomics consortium
- increased profile of key workers and public acknowledgement of healthcare scientists
- lower cost conferences
- breathing space to catch up on backlogs
- new skills for volunteers in covid labs
- Pharmacogenomic drugs approved for 1st line therapy instead of chemo
what are national level covid pandemic impacts?
- increased knowledge of COVID and RNA-based vaccines in the public domain
- increased understanding of genetics of SARS-coV-2 virus
- creation of COVID-19 genomics UK consortium for WGS of covid
- delays to major developments eg. WGS
- delays to GLH reorganising
what are the key points involved in major incident planning?
- business continuity plan
- workforce planning
- redeployment
- communication with service users and staff
- Datix - record incidents
- prioritise urgent samples
- risk assessments and document decisions in quality management system
what is included in a business continuity plan?
- outlines minimum levels of service achieved during a major incident eg. prenatal, outsource testing
- estimated timeframe of disruption
- defines risk and how they may affect service eg. fire, IT disruption, staffing
- recovery plan
which referrals should be prioritised when there is a major incident?
- urgent cancer diagnoses, to inform therapy or MRD monitoring, chimerism testing for SC ttransplant monitoring, prenatal diagnosis, pregnant carrier testing, rapid exome for NICU/PICU, NBS, therapy-informed testing eg. BRCA, neonatal diabetes
what does recovery plan from pandemic involve?
- audits of sample numbers TATs
- new ways of working
- feedback from staff
- restore TATs
- restore UKAS, accreditation, training
what are the advantages of genomic test directory?
- equity of access
- up to date with most appropriate technology for best diagnosis and clinical outcome
- standardised testing
- introduce new tests in-line with research and evidence
what is the purpose of panel app?
expert review and consensus on which genes related to clinical indication
- manually curated
- repository for gene panels in the NHSE Genomic Medicine Service and mapped to the test directory
- addition of new genes, STRs and CNVs as evidence emerges
what factors need to be considered when introducing a new test?
- is there a clinical need? prevalence, severity, expected samples and workload, is the service provided elsewhere?
- is there clinical demand? who is requesting and who would refer, would it be a screen or diagnosis?
- is there clinical utility - is there a treatment? would it diagnose a new disease? is there low penetrance, environmental effects, would there be predictive or prenatal testing, would it improve health?
- is it legal/ethical? incidental findings, prenatal testing, predictive testing, data access and storage, paternity testing, sexing
- technical testing strategy - test type, no of genes, hot spots, alternative tests (pre-screen IHC, biochemical, methylation), accuracy, reliability, sensitivity, specificity, false negs and positives, IQC, uncertainty of measurement, intermediate outcomes (premutations, mosaicism), incidental findings, sample types,
- how would new test impact on practice - workload, staffing, time to set up (validation, equipment)
- will new test replace an old one? increased TAT? less DNA? national guidelines and EQA, positive and neg controls, confirmation with another test?
- budget - consumables, equipment, staff, competitive price, funding, maintenance costs, business case required,
- skills and training - workload, external training available? support for troubleshooting, new starters needed - consider annual leave and sickness, IT and bioinformatics, health and safety, COSHH RIDDOR, SOPs
-equipment & lab- new equipment? can current equipment be used? automation? can equipment be used for other tests? is there space? - population factors - incidence, regional or national, variable expressivity, penetrance, carrier frequency, ethnicity-specific, as age, gender, or co-morbidities may affect the accuracy
- background work - research clinical, molecular, inheritance, acceptance criteria, guidelines, clinicans are aware, assay, reagents, equipment and positive controls
- validation - SOPs, screen known samples, Test samples in parallel using old/new method, demonstrate repeatability, accuracy robustness, examination, vertical & horizontal audit, review sample figures of expected vs observed, EQA scheme, follow ISO
- implement service - authorise SOP, ensure staff trained, design worksheets and info folders, report templates, provide info, BPGs, user-satisfaction surveys
ACCE framework (Analytical validity, Clinical validity, Clinical utility, and ethical legal and social implications) should be used as part of the evaluation process.
- request feedback from users and act on feedack to optimise service
- ongoing verification - review of trends in process by audit, report, prioritise and resolve errors,
what is UKAS Accreditation to Standard ISO 15189?
- Globally recognised standard specific for medical laboratories
- focus on patient care and safety
- sets out standards for quality management systems
- demonstrates quality and reliability of the diagnostic services.
- full assessment every 4 years with surveillance annually in-between- expected to improve quality in-between and address non-conformance
- clinical assessors review docs, witness procedures and interview staff
what is a quality management system?
Collection of process focussed on meeting service requirements and improvements
ensures tests/service are fit for purpose
Quality of results- compliance with specification
Compliance to ISO15189 requirement for quality and competence
- be subject to annual review and continual improvement
- monitors effectiveness to safeguard organisations and public
- management of QMS carried out using Q-pulse - Allows for management of document control, audits, incident reporting and equipment maintenance
- need quality policy and manual and quality manager
- continual improvement
what areas should be covered in a quality management system?
- roles and responsibilities
- document control
- EQA
- non conformance and preventative/corrective measures
- Resolution of complaints
- risk assessment
- audit
- management review and actions
- training, competency, PPRs,
- validation and verification, documentation and measurement of uncertainty
- IQC
- Lab equipment, reagents and consumables, including safety, maintenance and repair and record keeping
- Pre-examination process; request forms, information for users, sample collection and sample reception
- Post- examination processes – review, reporting and release of results
what is clinical governance?
A system through which organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish
- Three key attributes:
1. Recognisably high standards of care.
2. Transparent responsibility and accountability for those standards.
3. Constant dynamic of improvement.
achieved through trust boards and BSGM.
what are the components of clinical governance?
Clinical audit - review of clinical performance, refining clinical practice as a result and the measurement of performance against agreed standard. EQA is a component of this.
Clinical effectiveness - how well does the intervention work?
Education and training - CPD
Risk management - considered and balanced
Openness - open to public scrutiny
Research and development - review literature and develop guidelines and put into practice
Clinical information and information technology - use info to improve patient care
Patient and public involvement - patient centered
Staffing and staff management
what is risk management?
risk = “the potential that a chosen action, inaction or activity will lead to an undesirable outcome”.
Risk management is about minimising these risks by:
- Identifying what can and does go wrong during care
- Understanding the factors that influence this
- Learning lessons from any adverse events
- Ensuring action is taken to prevent recurrence
- Putting systems in place to reduce risks
- Clinical incidents reported
give examples of risk management in a genetics lab?
• Manual handling training
- COSHH assessments
- • Prevention of infection - PPE. risk assessments and SOPs in place
- Adverse Incident Reporting - Patterns and trends should be analysed and changes made to policies and procedures and/or feedback provided to staff where appropriate > put action plan in place
- • There is a legal requirement, under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 1995, for some incidents to be reported to the Health and Safety Executive (HSE),
what is a lab audit?
A laboratory audit is an assessment performed to demonstrate that the laboratory’s operations are according to regulatory standards and accreditation regulations, such as ISO 15189. It also detects any deviation in their processes that could affect the quality system.
can be external eg. UKAS or NEQAS or internal. ensure that examination processes are being conducted to agreed procedures and correctly performed. It is a system of comparing reality with requirements. Enables improvement of QMS.
horizontal = • Examines one part of a process applied to more than one item
vertical = • Examines more than one part of a process on one item.
Examination = witnessing of a laboratory procedure as it is performed to ensure compliance with the SOP
what is a clinical audit?
a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria
what is IQC?
activities undertaken to detect, reduce and correct deficiencies in a laboratory’s internal analytical process which gives confidence that the test if performing well
what is verification?
what is validation
verification = ‘Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled’ (doing test correctly)’
If a suitable performance specification is available, it is necessary to check that the new test meets this specification within the laboratory (verification).
Verification is also appropriate when a new test is introduced that uses a well-established method within the lab.
validation = ‘Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled’ (doing correct test)
Validation is required when there is no suitable performance specification available and the performance characteristics of the test need to be defined.
-
Session 1: DNA and chromosome structure, function and gene discovery222
-
session 6: cancer genetics & treatment170
-
Session 2: Laboratory techniques and bioinformatics194
-
mixed SAQs93
-
Session 3: Modes of inheritance and constitutional genetics181
-
session 7: lab management42
-
session 6: prenatal105
-
session 5 population genetics63
-
Hot topics12
-
essays1
