Core Laboratory Director
Balance arrival peaks, analyzer redundancy, autoverification, reagent inventory, and 99th-percentile turnaround time.
The same instrument family can create different value and risk in a core lab, satellite site, research workflow, or distributed testing network.
Balance arrival peaks, analyzer redundancy, autoverification, reagent inventory, and 99th-percentile turnaround time.
Define precision, reportable range, carryover, lot comparison, proficiency testing, and document retention.
Map ASTM E1394 or HL7 v2.5.1 messages, exception logic, user roles, downtime procedures, and audit trails.
Assess staffing by shift, manual touches, reflex rules, sample routing, and the cost of delayed or repeated testing.
Control protocol versions, centrifugation force and time, rotor limits, sample traceability, and study change records.
Model instrument, reagent, controls, calibrators, consumables, service, training, and downtime across the contract term.
The checklist is a scoping aid. It does not select a product or replace a laboratory-developed validation plan.
| Decision dimension | Centralized core laboratory | Distributed or point-of-care route |
|---|---|---|
| Analytical control | Concentrated QC oversight, broader menu, higher automation potential | More sites and operators increase training and comparability burden |
| Turnaround path | Transport and accession time may dominate urgent specimens | Result can be nearer the care decision, but operator workflow matters |
| Economics | Lower per-test cost may emerge at sustained scale | Faster decisions can matter more than reagent cost for selected pathways |
| Governance | One validation and accreditation center is simpler to govern | Each location needs controls, competency, connectivity, and exception handling |
Include specimen types, hourly arrivals, test menu, current interfaces, quality standards, and service constraints.