28/10/2025
🌐 Questions to Ask When Purchasing New Machines for a Clinical Laboratory ❓
Phase 1: Analytical Performance & Specifications
What are the key analytical performance characteristics? (e.g., precision/%CV, accuracy, reportable range, analytical sensitivity).
What is the throughput? Is it measured in tests per hour (TPH)? Does this include the reagent loading time? Is it the same for stat vs. batch testing?
What is the sample-to-result time (TAT for the instrument itself)?
What is the sample capacity? (How many tubes/trays can it hold?).
What is the reagent capacity and onboard stability? (How many tests can it run without refill? How long do reconstituted reagents last?).
What is the level of automation? Does it have auto-dilution, auto-reflex testing, and sample rerun capabilities?
Phase 2: Clinical Utility & Workflow Integration
What tests/methods are available on the platform? Does it meet our test menu needs?
How does it fit into our existing workflow? Can it interface with our Laboratory Information System (LIS) and/or Hospital Information System (HIS)?
What is the sample type requirement? (Serum, plasma, urine, CSF? Does it require a specific tube type?)
What is the dead volume requirement? (How much sample is consumed per test and wasted?).
Does it support pediatric samples? (This is critical for small volume requirements).
Phase 3: Regulatory & Compliance
Is the instrument and its assays FDA-cleared/approved? (Or relevant regulatory body like CE-IVD, etc.).
What is required for regulatory compliance? (e.g., Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)).
Does the vendor provide a 510(k) submission number or other regulatory documentation?
How does the system handle data integrity and audit trails in compliance with regulations like CLIA, CAP, or ISO 15189?
Phase 4: Cost & Commercial Terms (Cost of Ownership)
What is the cost per test? This is often more important than the instrument's purchase price.
What are the reagent and consumable costs? Is there a required minimum purchase?
Is there a reagent rental agreement option? (Where you pay for reagents in exchange for a discounted/free instrument).
What are the costs for calibration material and quality control (QC) materials?
What is the warranty period and what does it cover?
Phase 5: Service, Support & Training
What is the service contract cost and what does it include? (Response time, parts, labor, preventive maintenance).
What is the Mean Time Between Failure (MTBF) and Mean Time To Repair (MTTR)?
What training is provided? For operators? For maintenance technicians? For super-users?
Does the vendor provide documentation for the Laboratory Procedure Manual?