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