This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya).

You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions.

www.GlobalHealthLaboratories.org

Laboratory Equipment Management

KEMRI (CGMRC) Wellcome Trust ProgrammeKilifi, Kenya.

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

Instrument Selection

• Laboratory instruments have become increasingly complex.

• Selecting the correct system for your needs requires a detailed programme of assessment and evaluation.

Instrument Selection • Analytical instruments;

• Blood Cell Counters

• Multi-chemistry analysers

• Stat – single assay instruments

• Spectrophotometers

• Flow Cytometers

• Molecular biology equipment

Instrument Selection • Equally important to correctly

select;

• Automatic pipettes

• pH meters

• Thermometers

• Water baths

• Centrifuges

• Incubators

• Fridges & Freezers, etc

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;

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

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

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

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?

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;

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

Installation

• Installation considerations (cont’d);

• Specifications for physical environment;

• Temperature tolerances• Humidity

• Dust

• Vibration

• load bearing

• Light, direct sun

• Space & ventilation

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;

Training

• Start-up & shut-down procedures

• Cleaning & maintenance

• Sample preparation & handling

• QC & calibration procedures

• Trouble shooting

• Data acquisition and storage

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.

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).

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.

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.!

Preventive Maintenance• routine cleaning

• adjustment,

• replacement of equipment parts

19/04/23 21

Equipment InventoryRecord: instrument type, model number,

serial number.location in laboratory.date purchased.manufacturer and vendor contact information.warranty, note expiration datespare parts

19/04/23 22

Equipment Management Benefits

Performance high level

Test resultsVariation/ Time

Lowers repair costs Lengthens

lifespan

Equipment Management: Benefits

High-level Performance

Test resultsEnsures Quality

Reduced Down-Time

Lowers repair costs Lengthens

lifespan

Instrument / Assay Backup

• Must ensure comparability of results with an equal level of IQC in place.