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2. Laboratory Equipment Management KEMRI (CGMRC) Wellcome Trust Programme Kilifi, Kenya.

3. Introduction Many factors need to be considered when selecting, and subsequently utilising, laboratory equipment; Initial Selection Assessment Budgeting Installation & Training Laboratory Evaluation Documentation Maintenance & Servicing Trouble-shooting

4. Instrument Selection Laboratory instruments have become increasingly complex. Selecting the correct system for your needs requires a detailed programme of assessment and evaluation.

5. Instrument Selection Analytical instruments; Blood Cell Counters Multi-chemistry analysers Stat – single assay instruments Spectrophotometers Flow Cytometers Molecular biology equipment

6. Instrument Selection Equally important to correctly select; Automatic pipettes pH meters Thermometers Water baths Centrifuges Incubators Fridges & Freezers, etc

7. Initial Selection Assessment Wide variety of instruments available on the market that perform similar functions Range in cost, complexity & function. Extremely important to select the CORRECT instrument for your needs;

8. Initial Selection Assessment Selection considerations; Throughput (sample capacity) Range of applications Versatility; able to use different sources of reagents or spares Sample volume Sample preparation QC and calibration requirements Level of technical skill required

9. Initial Selection Assessment Selection considerations (cont’d); Power and other service requirements Environmental requirements: Temp & humidity Adequate space available, remember ventilation Running costs; reagents, spares, maintenance & service, power consumption. Reliability & reputation

10. Initial Selection Assessment Selection considerations (cont’d); What level & quality of support/ backup is available for; Training Technical advice Service & Preventative Maintenance Rapid call out Reliable supply of reagents & spares

11. Budgeting Very important to consider TOTAL costs when budgeting for a new instrument; Instrument: Outright purchase vs Rental Delivery & installation Running costs; Service contract & emergency call-out Reagents, consumables & spares Controls & calibrators Services – electricity, water, gases Staffing requirements Backup system – purchase & running costs?

12. Installation Wherever possible a new instrument should be installed and commissioned by the supplier. If the customer is to install, detailed information must be supplied by the manufacturer, including;

13. Installation Installation considerations; Procedures for unpacking the instrument Detailed component list Instructions on what to do if the instrument is damaged - insurance? Specifications of service requirements; Voltage and power backup (UPS?) Water pressure & purity Gas supply Drainage H&S requirements - PPE

14. Installation Installation considerations (cont’d); Specifications for physical environment; Temperature tolerances Humidity Dust Vibration load bearing Light, direct sun Space & ventilation

15. Training Detailed training and instruction should be provided by a competent manufacturer’s representative, particularly in the case of major equipment. It is crucial that all operators are fully trained in all stages of the instruments operation including;

16. Training Start-up & shut-down procedures Cleaning & maintenance Sample preparation & handling QC & calibration procedures Trouble shooting Data acquisition and storage

17. Laboratory Evaluation Before an instrument is placed into routine operation a period of observation and staff familiarisation must be provided. This will help identify any inherent defects in the machine and allow staff to fully understand its capabilities and restrictions.

18. Laboratory Evaluation For analytical instruments, a full performance evaluation must be undertaken before patient/study samples can be analysed and the data utilised. This should include; Detailed instrument & assay validation (see separate session). Establish IQC procedures and determine control limits for all methods (refer to session on IQC).

19. Documentation All important details & documents must be filed and retained as part of your Equipment Inventory system; Dates, make, model, Serial No., Warranty, service supplier details and schedules, essential spares list, lab location, Service history logs. Detailed operational procedures/SOPs should be developed and implemented during the training and evaluation phases.

20. Develop a Maintenance Plan Routine Maintenance: Develop and document a detailed schedule of routine maintenance according to manufacturers instruction.  Scheduled Maintenance : includes service repair by manufacturer, calibration,  Function check plus any other problems Trouble Shooting: Occurrence Logs; details of all problems encountered and steps taken to rectify the incident – Corrective Actions – DOCUMENT.!

21. Preventive Maintenance routine cleaning adjustment, replacement of equipment parts 03/07/2015 21

22. Equipment Inventory Record:  instrument type, model number, serial number.  location in laboratory.  date purchased.  manufacturer and  vendor contact information.  warranty,  note expiration date  spare parts 03/07/2015 22

23. Equipment Management Benefits Performance high level Test results Variation/ Time Lowers repair costs Lengthens lifespan

24. Equipment Management: Benefits High-level Performance Test results Ensures Quality Reduced Down-Time Lowers repair costs Lengthens lifespan

25. Instrument / Assay Backup Must ensure comparability of results with an equal level of IQC in place.