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LIMS
Reagent Acceptance Testing
Surveillance Visits
Lara Cresswell
ACGS Genetics Quality & Accreditation workshop
17/05/2017
Overview
• LIMS
• Standard 5.10
• Reagent Acceptance Testing
• Standard 5.3.2.3
• Surveillance visits
• What to expect
• Own lab practice
• Questions
LIMS
• Standard 5.10 Laboratory Information Management
• Includes paper & computerised systems
• Includes office applications as well as equipment software
• Demonstrate access to data/information needed to
provide a service required by users
• Ensure patient confidentiality
• Documented procedure
• Mandatory IG training
Authorities and responsibilities 5.10.2
• Must be defined
• Includes maintenance & modification
• Includes all personnel who use the system
• Access patient information
• Enter information and results
• Amend information and results
• Authorise the release of results
• 3rd party IT management
• E.g. IBM
• Access to their documentation
Responsibilities
Third party/ IT Dept
• Data back up and storage.
• Internet and email usage
• Access control
• Malware and virus protection
• Network perimeter controls
• Portable devices and remote access
• Physical security
• Computer and network maintenance
• Security management and reporting
• Secure electronic communication
Lab SOP covers:
• Related SOPs
• Associated documents
• Related Risk assessments
• Access control
• Maintenance
• Software upgrades
• Acceptance testing
Associated documents
• Lab Storage and disposal of process and quality records
• Lab Business continuity plan
• Trust Business Continuity Management
• IM&T Business Continuity Plan
• Trust Technical Operations Backup and Restore
Processes
• Reference as external documents
• Change management
• Laboratory information management change form
Validation & verification of systems
• Same principles as reagents/consumables
• Validated by supplier, verified by lab before use
• Criteria for acceptance testing
• E.g. Standard set of array images for version upgrades
• Change management process• Proposal, approval, implementation plan, go live
• Don’t forget interfaces!
• Applies to bioinformatics pipelines
http://www.acgs.uk.com/media/1054695/7_2017-04-20_acgs_rlh.pdf
• IT change requests
• Access to their paperwork
• Don’t assume they know about links/interfaces
5.10.3 Information system management
• e) operated in a environment that complies with supplier
specification
• Which OS etc.
• months to organise upgrade to windows 7 and office 2010 to allow Shire upgrade, run Cytogenomics
• Significant IT project
• Lab resources
• Change management documentation
• f) ensure integrity of data
• Back ups
• System failures
Audit
• Verify that results are accurate when received
• Reports sent electronically/faxed
• Verify that they get there and are correct
• Lab responsibility for this
• Back up processes audited every 6 months
• IBM
• Annual audit of electronic systems
e.g. HaemoSys
Conclusions
• Scope of SOPs/policies has increased• More than just how to use the system
• Validation, verification, change management
• Require information from IT teams
• Must be in business continuity plans
• Cyber attacks
• Highlights vulnerabilities in NHS IT infrastructure
• Dated hardware/OS
• Reliance on hosting/ external links for service provision
• Onus on the lab even when 3rd party provider
• Must ensure comply with the standard
Reagent acceptance testing
• Standard 5.3 Lab equipment, reagents & consumables
• 5.3.2.3 reagents and consumables - acceptance testing
“Each new formulation of examination kits with changes in reagents or
procedure, or a new lot or shipment, shall be verified for performance before
use in examinations.
Consumables that can affect the quality of examinations shall be verified for
performance before use in examinations”
• Significant increase in testing since ISO accreditation
What needs acceptance testing
• Everything that can affect the outcome of the examination procedure• New formulations of kits
• Changes in reagents and/or procedures
• New lot numbers
• New shipments even if same lot#
• Effects of transit
• Consumables: tubes, pipettes, slides
• Ready made & home made reagents
• Combinations of the two
• Make up much larger batches to reduce testing
• Segregation of non-verified from verified reagents
How?
• The level & method of verification varies depending on the
reagent and its intended use
• Consideration given to the cost of the additional reagents
that will be required to complete
• Verification by first use of the new batch of a reagent
• Verification using duplicate tests
• Reagents that need to be verified for performance on
Long term cultures
• More involved, takes longer
Reagent testing records
• Manufacturer’s reagents• Used for reagents obtained from the manufacturer in a ready to use
form that are simply aliquotted by the laboratory into convenient volumes before use.
• Colcemid
• Trypsin for G banding
• In house reagents• Used for any reagent that is made up by the laboratory and may
consist of a number of components.
• Complete BM media
• Trypsin-EDTA
• Leishman’s stain
• Combinations - ready to use but mixed before use• Hepes is a component of complete blood set up/ blood washes/BM
media
Verification Sheets
• Includes the requirements for records set out in 5.3.2.7
• Also have prompt sheets to show what needs testing
In house verification
Must document who has prepared the reagent
Acceptance criteria
• Must be a narrative
• Don’t just use yes/no
• Included examples on back of sheets
What happens if acceptance testing fails?
• Re-test if appropriate
• 5.3.2.6 Adverse incident reporting
• “Adverse incidents and accidents that can be attributed
directly to specific reagents or consumables shall be
investigated and reported to the manufacturer and
appropriate authorities, as required”
• MLPA kit
• Methanol batch
Conclusion
• Increase in the amount of verification
• Applies to all reagents/consumables
• Important to have a full audit trail
• Process should be tested regularly through audit to
ensure compliance
• Horizontal, vertical audit
• Competency assessment/re-assessment
Surveillance visits
• Accreditation is a 4 year cycle
• 6 months post grant of accreditation first surveillance visit
• Annual surveillance in the same month thereafter
• UKAS document LAB3 Conduct of UKAS lab assessments Pg 11
• 4 week TAT for improvement actions!
• Assessment manager can sign off
• Not everything checked at surveillance
• Cover everything in 4 year cycle
• AMR, audits, complaints covered each time
• It does get easier!
Own experience
• Transition assessment in 2014 40 IAs (7 ISO only)
• First surveillance and ETS 17 IAs and 1 recommendation
• Second surveillance visit 13 IAs
• January is our accreditation month!
• Review report for what to expect at next SU visit
• Take notes during discussions for observations
• Discuss any changes to service with the AM
• Incl. significant staff changes
Summary
• LIMS
• Emphasis on lab to ensure compliance with standard
• Change management is a big factor
• Acceptance testing
• Requirements for 15189 have increased workload
• Improved record keeping; full audit trail
• Surveillance visits
• Ensures process of continual improvement
• Annual visit requires consistent focus
• Need to demonstrate development of QMS over time