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Module_4_GCLP_LABORATORY_EQUIPMENT.ppt
- 1. 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
- 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 31/01/2023 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 31/01/2023 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.
Editor's Notes
- Proper management of the equipment in the laboratory is necessary to ensure accurate, reliable, and timely testing. It is the responsibility of the laboratory management to: oversee all the equipment management systems in the laboratory; ensure that all persons who will be using the instruments have been appropriately trained and understand how to both properly operate the instrument and perform all necessary routine maintenance procedures. Oversight of an equipment management program includes: assigning responsibilities for all activities; assuring that all personnel are trained on operation and maintenance; monitoring the equipment management activities: review all equipment records routinely; update maintenance procedures as necessary; ensure that all procedures are followed.
- Proper management of the equipment in the laboratory is necessary to ensure accurate, reliable, and timely testing. It is the responsibility of the laboratory management to: oversee all the equipment management systems in the laboratory; ensure that all persons who will be using the instruments have been appropriately trained and understand how to both properly operate the instrument and perform all necessary routine maintenance procedures. Oversight of an equipment management program includes: assigning responsibilities for all activities; assuring that all personnel are trained on operation and maintenance; monitoring the equipment management activities: review all equipment records routinely; update maintenance procedures as necessary; ensure that all procedures are followed.
- As the laboratory puts an equipment management program in place the following elements should be considered: Selection and purchasing — When obtaining new equipment what criteria should be used to select equipment? Should equipment be purchased, or would it be better to lease? Installation — For new equipment, what are the installation requirements, and who will install the new instrument? Calibration and performance evaluation — What is needed to calibrate and validate that the equipment is operating correctly? How will these important procedures be conducted for both old and new instruments? Maintenance — What maintenance schedule is recommended by the manufacturer? Will the laboratory need additional preventive maintenance procedures? Are current maintenance procedures being conducted properly? Troubleshooting — Is there a clear procedure for troubleshooting for each instrument? Service and repair — What is the cost? Can the laboratory obtain the necessary service and repair in its geographical area? Retiring and disposing of equipment — What must be done to dispose of old equipment when it needs to be replaced?
- Some criteria to consider when selecting laboratory equipment are listed below. Why and how will the equipment be used? The instrument should be matched against the service the laboratory provides. What are the performance characteristics of the instrument? Is it sufficiently accurate and reproducible to suit the needs of the testing to be done? What are the facility requirements, including the requirements for physical space? Will the cost of the equipment be within the laboratory’s budget? Will reagents be readily available? Will reagents be provided free of charge for a limited period of time? If so, for how long? How easy will it be for staff to operate? Will instructions be available in a language that is understood? Is there a retailer for the equipment in the country, with available services? Does the equipment have a warranty? Are there any safety issues to consider?
- Equipment Acquisition - Is it better to purchase, rent or lease equipment? When making this decision, it is a good idea to factor in repair costs. The initial cost of an instrument may seem reasonable, but it may be expensive to repair. Also consider savings that could be negotiated if the laboratory needs more than one piece of equipment.
- Before purchasing ask if: wiring diagrams, computer software information, a list of parts needed, and an operator’s manual are provided; the manufacturer will install the equipment and train staff (covering travel expenses as necessary) as part of the purchase price; the warranty includes a trial period to verify that the instrument performs as expected; the manufacturer’s maintenance can be included in the contract and if so, whether maintenance is provided on a regular basis.
- Determine if the laboratory can provide all the necessary physical requirements, such as electricity, water, and space. There must be adequate room to move the equipment into the laboratory; consider door openings and elevator access.
- Before equipment is installed, verify that all physical requirements (electrical, space, doors, ventilation, and water supply) have been met. Other things to consider are: The vendor’s responsibilities for installation should be confirmed in writing prior to beginning the installation process. A checklist of the expected performance specifications should be developed, so that performance can be quickly verified as soon as the equipment is installed. Whenever possible, it is best to have the manufacturer install laboratory equipment; this will likely improve the conditions of the warranty, and also may ensure that the installation is done properly and quickly.
- If equipment is installed by the laboratory: check that the package contents contain all of the parts; make a copy of any software that is part of the system; do not allow the equipment to be used before it is completely installed, performance is verified, and testing personnel are trained.
- Post – Installation: After equipment has been installed, the following details need to be addressed before putting the equipment into service: assign responsibility for performing the maintenance and operation programs; develop a system for recording the use of parts and supplies; implement a written plan for calibration, performance verification, and proper operation of the equipment; establish a scheduled maintenance program that includes daily, weekly, and monthly maintenance tasks; provide training for all operators; only personnel who have been trained specifically to properly use the equipment should be authorized as operators.
- Equipment Performance evaluation: Prior to testing patient specimens, it is important to evaluate the performance of new equipment to ensure it is working correctly with respect to accuracy and precision. In addition, test methods using kits or laboratory instruments need to be evaluated for the ability to detect disease (sensitivity, specificity, positive and negative predictive value), and to determine normal and reportable ranges.
- Verification of manufacturers’ performance claims: Manufacturers provide performance evaluations for testing methods using their kits or instruments, and include the information in the package inserts or operators’ manuals. However, laboratories need to verify the manufacturers’ performance claims, and demonstrate they can get the same results using the kits or equipment in their laboratory, with their personnel. Some of the steps that should be followed to verify performance include: testing samples with known values and comparing the results to the expected or certified value; if equipment is temperature-controlled, establishing the stability and uniformity of the temperature.
- As a follow-up step, the laboratory director or designee must consistently review, sign, and date all documentation at least monthly to establish an audit trail. The laboratory should establish tolerance limits for equipment temperatures and other monitored conditions (e.g., %CO2, liquid nitrogen levels) that are consistent with manufacturers’ guidelines and procedural activities because certain reagents and equipment perform optimally under specific conditions. The laboratory must document all scheduled preventive maintenance, unscheduled maintenance, service records, and calibrations for all equipment utilized. This documentation should be readily accessible to operators. The lab should also maintain daily (or “dates of use”) record of temperatures and other monitored conditions (e.g. humidity). For observations that fall outside of designated tolerance ranges, the laboratory must maintain appropriate documentation of corrective action for these out-of-range temperatures and other conditions.
- Equipment Maintenance Plan: A maintenance plan will include preventive maintenance procedures as well as provision for inventory, troubleshooting, and repair of equipment. When implementing an equipment maintenance program, some of the initial steps will include what follows. Assign responsibility for providing oversight. Develop written policies and procedures for maintaining equipment, including routine maintenance plans for each piece of equipment. The plan should specify the frequency with which all maintenance tasks should be performed. Develop the format for records, create logs and forms, and establish the processes to maintain records. Train staff on the use and maintenance of the equipment, and assure that all staff understand their specific responsibilities.
- Laboratory staff must conduct preventive maintenance and service per manufacturer specifications by following documented daily, weekly, and/or monthly routine maintenance plans for all equipment utilized to ensure that all equipment performs consistently and reproducibly during the conduct of the trial. Preventive maintenance includes measures such as systematic and routine cleaning, adjustment, and replacement of equipment parts at scheduled intervals. Manufacturers generally recommend a set of equipment maintenance tasks that should be performed at regular intervals: daily, weekly, monthly, or yearly
- The laboratory should keep an inventory log of all equipment in the laboratory. The log should be updated with information on new equipment, as it is added, and include documentation of when old equipment is retired. For each piece of equipment, the equipment inventory log should have a record of: instrument type, make and model number, and serial number of the instrument, so that any problems can be discussed with the manufacturer; date the equipment was purchased, and whether it was purchased new, used, or reconditioned; manufacturer/vendor contact information; presence or absence of documentation, spare parts, and maintenance contract; warranty’s expiration date;
- A well develope equipment maintenance plan will ensure that the equipment performs at maximum efficiency and will increase the lifespan of the equipment. This will also help to prevent: inaccurate test results due to equipment failure delays in reporting results lower productivity large repair costs.