Abstract Background Persistent daily quality control (QC) failures for Vitamin B12 on one of three Abbott Alinity i analyzers prompted an in-depth investigation. Patient testing on the affected analyzer was suspended to prevent inaccurate results, and the issue was escalated to the vendor for further troubleshooting. It was noted that the area surrounding the affected analyzer was consistently warmer than other parts of the laboratory, indicating a potential localized heat dissipation issue. Methods A systematic root cause analysis was undertaken to identify factors contributing to the QC failures. Potential causes—including incorrect QC handling, calibration errors, reagent contamination, improper storage conditions, and instrument malfunctions—were thoroughly investigated and ruled out. Attention then turned to environmental factors, as the affected analyzer was found to be operating at an elevated temperature of 31.6°C, above the manufacturer’s allowable range of 15–30°C. The working assumption was that poor airflow and suboptimal analyzer placement resulted in inadequate heat dissipation. As a temporary measure, a fan was placed near the affected analyzer to enhance airflow and regulate the ambient temperature. Daily QC performance was closely monitored, and an interlaboratory comparison with another laboratory’s Abbott Alinity i analyzer was conducted to validate result accuracy. Results The installation of the fan resulted in stabilization of the analyzer’s temperature within the acceptable range (15–30°C), and QC performance returned to expected levels. A precision study confirmed that the coefficient of variation (%CV) remained within Abbott’s specification (=10%). Additionally, the interlaboratory comparison demonstrated a strong correlation (r = 0.996, slope = 0.892), confirming the reliability of the patient results. However, following adjustments to the central air conditioning system, the fan was removed, and QC failures promptly recurred. Reinstating the fan immediately resolved the issue once again. Given the persistent temperature instability, hospital engineers conducted a comprehensive review of the laboratory’s airflow and temperature control systems. A permanent resolution was ultimately achieved by readjusting the existing system and installing additional air conditioning vents, which ensured that the affected area maintained the required temperature stability. Conclusion This case highlights the significant impact of localized temperature fluctuations on the performance of sensitive immunoassays, such as Vitamin B12 testing on the Abbott Alinity i analyzer. Inadequate airflow and poor heat dissipation can lead to QC failures and compromise patient result reliability. Although manufacturers provide detailed heat generation and clearance requirements in operating manuals, these guidelines are often overlooked despite their critical role in maintaining assay integrity. Routine environmental monitoring, strict adherence to manufacturer specifications, and proactive collaboration between laboratory personnel, equipment vendors, and hospital engineers are essential for sustained quality performance. This experience reinforces the need for comprehensive environmental assessments and engineering interventions to safeguard assay performance and patient safety in laboratory settings.
Lam et al. (Wed,) studied this question.