By Vvon Engineering Team | Published | Updated
Compare chemistry analysers by test menu, peak workload, reagent compatibility, quality control, infrastructure and lifecycle cost.
Medical equipment RFQ checklist (TXT)
A chemistry analyser must cover the required test menu and peak turnaround, with affordable reagents and dependable support. Rated tests per hour is one input; water, power, consumables, quality control and maintenance determine whether that capacity can be used.
Use the clinical analysers and diagnostics category to compare the current BIOBASE and Infitek listings. Include the approved test menu, workload, reagent system, controls, connectivity and consumable requirements. The clinical laboratory procurement checklist helps record the supply and acceptance scope. The responsible clinical team must verify the exact configuration and documentation before purchase.
List reportable tests, sample types, routine daily volume and the peak arrival pattern. Allow for urgent work, calibration, quality control, repeats and maintenance when estimating whether the offered analyser can meet reporting deadlines.
Then split the menu into three groups, because they carry different consequences.
If electrolytes form a substantial part of the workload, check the ISE module’s consumables, maintenance and downtime behaviour. Ask whether the remaining analyser functions can continue during an ISE fault and agree a validated backup or referral arrangement.
Reagent compatibility varies by platform. A closed system generally uses specified reagent packs; an open system may permit laboratory-programmed applications and compatible third-party reagents. Confirm what the offered model actually allows, together with the manufacturer’s intended use and support conditions.
| Closed system | Open system | |
|---|---|---|
| Reagent source | Specified supported packs | Compatible reagents within the platform’s intended use |
| Method setup | Manufacturer-defined applications, locally verified | Application setup plus appropriate verification or validation |
| Supply interruption | Depends on local stock and alternatives | Alternatives still need compatibility and performance assessment |
| Quality responsibility | Laboratory retains responsibility for verified results and QC | Laboratory retains responsibility for verified results and QC |
| Cost comparison | Contract pricing, consumption and waste | Reagent price plus method work, QC and waste |
ISO 15189 applies to the laboratory’s quality and competence, not to a preference for an open or closed analyser. Both approaches require appropriate method verification or validation and ongoing quality assurance. Compare the staff time and evidence required for the actual methods; neither design guarantees accreditation or savings.
Ask one question of any closed system bidder and get the answer in writing: what is the reagent price today, and what mechanism sets the price in year three? An attractive instrument price attached to an uncapped reagent commitment is not a saving, it is a deferred cost with no ceiling.
Build the running-cost schedule from the manufacturer’s consumption data and the laboratory’s expected work. Include the following items where they apply.
Compare lifecycle cost over a stated period using the same workload and assumptions for every bid. Show reagent-price, utilisation and service-cost sensitivity instead of presenting the result as a guaranteed saving.
Water requirements vary: some analysers need a continuous purified-water feed, others use a reservoir or different arrangement. Specify quality, flow, pressure, daily consumption and sanitisation from the offered analyser’s installation instructions, then select the compatible treatment system.
Analyse the actual source water and consider seasonal and storage changes when specifying treatment and pretreatment. Size reservoirs and circulation to the validated water-system design, and document monitoring and sanitisation; do not prescribe a one-day tank or a single treatment train for every analyser.
Confirm the liquid-waste route and any chemical or biological waste restrictions. An approved closed waste container may be appropriate for some systems; direct drainage is not universally required. Avoid improvised containers or unapproved discharge.
Ask the manufacturer what happens after a power interruption during each stage of a run. Recovery, repeat analysis and recalibration needs depend on the platform and the event; include the consequences in the continuity plan.
Check specified temperature, humidity, clearance and heat rejection against the room design. Cooling redundancy may be justified by service criticality, but two air conditioners are not a universal requirement. Include a response plan for conditions outside the instrument’s operating range.
Before contracting, ask where trained service staff are based, how parts are sourced and how faults are escalated. Reliability also depends on the device, installation, use and maintenance, so compare the full support proposal.
Define response and escalation targets in the contract, including when the clock starts, support hours and exclusions. Distinguish acknowledgement, attendance and repair completion rather than treating them as the same commitment.
Set the QC plan from assay requirements, risk and the laboratory quality system. Budget the required materials and review rules, and investigate control failures before issuing affected results. A single generic control frequency is not appropriate for all methods.
Keep installation, method, water-quality, environmental and service records under the laboratory’s document-control process. Require supplier handover at commissioning and maintain the file as the system changes.
Laboratory quality and competence reference: ISO 15189:2022.
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