LIMS Reagent Acceptance Testing Surveillance Visits. Lara Cresswell ACGS Genetics Quality & Accreditation workshop 17/05/2017

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1 LIMS Reagent Acceptance Testing Surveillance Visits Lara Cresswell ACGS Genetics Quality & Accreditation workshop 17/05/2017

2 Overview LIMS Standard 5.10 Reagent Acceptance Testing Standard Surveillance visits What to expect Own lab practice Questions

3 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

4 Authorities and responsibilities 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 3 rd party IT management E.g. IBM Access to their documentation

5 Responsibilities Third party/ IT Dept Data back up and storage. Internet and 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

6 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

7 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 IT change requests Access to their paperwork Don t assume they know about links/interfaces

8 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

9 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

10 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 3 rd party provider Must ensure comply with the standard

11 Reagent acceptance testing Standard 5.3 Lab equipment, reagents & consumables 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

12 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

13 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

14 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

15 Verification Sheets Includes the requirements for records set out in Also have prompt sheets to show what needs testing

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17 In house verification Must document who has prepared the reagent

18 Acceptance criteria Must be a narrative Don t just use yes/no Included examples on back of sheets

19 What happens if acceptance testing fails? Re-test if appropriate 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

20 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

21 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!

22 Own experience Transition assessment in 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

23 Summary LIMS Emphasis on lab to ensure compliance with standard Change management is a big factor Acceptance testing Requirements for 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