TABLE 3.
Issues surrounding laboratory medicine management and key solutions.
| Issues | Current status | Key solutions | New management problem |
|---|---|---|---|
| Rapid‐launched LDTs | Aim to optimal experimental conditions and sufficient clinical practice (time‐consuming) | Achieve the minimum clinical application requirements in equipment, personnel, SOP | Consensus on minimum clinical application requirements; reliable performance indicators definition (qualitative and quantitative) |
| Abundant testing demand on LDTs | Small‐scale test volumes in reference laboratories or few qualified hospital laboratories | Pooling samples to increase molecular testing throughput | Evaluate the sensitivity, specificity, reproducibility and verify optimal pooling approach 69 ; Define distinctive screening strategy in different populations and areas |
| POCT | Large‐scale instruments not applicable; Non‐professionals involved | Mobile biosafety laboratories 70 |
Instrument quake‐proof in mobile biosafety laboratories; operator body shape; hardware circuit debugging; software debugging; daily maintenance |
| LIS | Data outside laboratory disconnection with LIS (manual recording or miss data) | Smartphone‐based systems; intelligent connected devices | Remote data debugging; software settings |
| Big data survey | Survey data from regular regional meetings or publications | Real‐time data sharing from wider regional clinical laboratories; establishment of AI framework | Statistical software networking; survey data analysis; specific personnel training; regional organization and local government conduct and support; appropriate analysis methods for AI; limitations of machine learning algorithms |
| Laboratory material and personnel resources shortage | Resources and personnel in separate laboratory or department | Emergency resources reserve (acknowledge local healthcare plans, administrative duties, and political context); regional sharing and policy deployment; available staff from other groups, regional clinical laboratory or remote assistance work | Need accurate strategy and policy guidance; Identify staff regulations (eg, time on turn, recovery) under urgent situation; consensus on personnel training, SOP, report, and data interpretation |