LIMS Stock Control for ISO 15189

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1 LIMS for ISO Fiona Byrne Senior Genetic Technologist

2 Our Story Reasons for developing an electronic LIMS-based How we use our How it meets UKAS ISO standards How we address Reagent Verification Fail-safes & making the system robust Benefits Further developments

3 Why did we develop our GeneWorks? ISO UKAS Accreditation Application Inefficient and inaccurate GeneWorks previous paper-based system Reliant on users entering the data Lab/IT Difficult to monitor ISO collaboration Difficult to collate data Time-consuming to use in troubleshooting New requirement for Effective verification & process (ISO 15189) more difficult to meet with paper system Efficient Monitor stock levels Stock Highlight low stock Control Our in-house LIMS: GeneWorks

4 Homepage Features Overview of reagent/consumable batches Suppliers Products Verification Reports Low stock Stock approaching expiry date

5 Homepage

6 Suppliers

7 Products In-house Reagents

8 Verification Identified by Status Received Verification Requested Verification Failed Verified Completed Disposed Returned to Supplier Received Verification Requested Verified Received Verification Requested Verification Failed Verification Requested Verified

9 Expiry date Lot number How are we meeting ISO UKAS Requirements? Manufacturer s name Section Reagents and consumables Condition on receipt Verification records

10 How are we meeting ISO UKAS Requirements? Store reagents & consumables according to manufacturer s specifications

11 How are we meeting ISO UKAS Requirements? In-house Reagents

12 Managing reagent batches Log new reagent batches Log in-house reagent batches Log usage of reagents Verify reagents for use Monitor stock levels Highlight low stock and generate reports

13 Fail-safes Making the system robust What if I try to.? Expired Status = Disposed use an unverified reagent use an expired or on a worksheet disposed reagent open a reagent that has already been opened: start a reagent that has not been verified: Reagents cannot be used when the Worksheet is completed, GeneWorks automatically adds a Verification Request and assigns the Verification Run, changing the status to Verification Requested

14 Benefits GeneWorks as our own in-house LIMS gives us a personalised, user-defined LIMS Better monitoring of stock levels from your desk Stock overview at your fingertips and available to all staff no need to trawl through paperwork stored in the lab! Better troubleshooting ability all reagent information in one place Prevent use of expired or unverified reagents Reports flexibility to create reports with relevant data Comprehensive audit date, time and user for every action

15 Further Developments FISH probes Tailored to capturing specific data Further automation with integration of Worksheets and Already adding verification requests - plans to automatically update the verification result and Start dates Link to ordering system Costs, usage data, order dates, reminders, etc.

16 Any Questions GeneWorks Lab/IT collaboration ISO Effective & Efficient Stock Control

17 Managing reagent batches Log new reagent batches Log in-house reagent batches Log usage of reagents Verify reagents for use Monitor stock levels GeneWorks LIMS

18 GeneWorks LIMS Log new reagent batches

19 GeneWorks LIMS Log in-house reagent batches

20 Stock usage

21 GeneWorks LIMS Verify reagents for use

22 Monitoring Stock Levels

23 Segregating Unverified and Verified reagents Take me to it / Snooze / Snooze All / Acknowledge GeneWorks LIMS

24 Aliquots - GeneWorks St. George's University Hospitals NHS FT

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