Key Laboratory Positions
The most critical position to establish in any laboratory is the Laboratory Director, who bears ultimate responsibility for all technical and administrative operations, quality assurance, and regulatory compliance. 1
Essential Position: Laboratory Director
The Laboratory Director serves as the cornerstone of laboratory operations and must be established first, as this individual carries comprehensive oversight responsibilities that directly impact patient safety and diagnostic accuracy 1.
Technical Responsibilities of the Director
The director's technical duties are fundamental to ensuring accurate patient results:
- Supervises all laboratory work performed, demonstrated by signing all laboratory reports to verify accuracy and appropriateness 1
- Provides consultation to referring physicians regarding test selection, interpretation of results, and clinical significance of findings 1
- Ensures appropriate methodologies and information are utilized for data production and interpretation 1
- Selects and oversees reference laboratories when testing is performed externally 1
- Monitors quality control and quality improvement programs, including participation in interlaboratory comparison programs and performance evaluation 1
Administrative Responsibilities of the Director
The director's administrative functions are equally critical for laboratory operations:
- Ensures employment of qualified personnel, establishes performance standards, and provides ongoing educational training for all staff members 1
- Sets organizational goals and allocates resources including personnel, physical space, and working capital 1
- Promotes laboratory safety by facilitating a safe working environment and ensuring staff safety training is conducted 1
- Ensures regulatory compliance with all applicable accrediting agencies and federal, state, and local regulations 1
Director Qualifications
For specialized laboratories such as DNA-based genetic testing facilities, directors should possess ABMG eligibility or certification in clinical molecular genetics with 4 years of postdoctoral experience, including at least 2 years specifically in clinical molecular genetics testing 1. However, research demonstrates that while doctoral degrees have been traditionally required by federal regulations since 1971, the director's earned doctorate alone is neither necessary nor sufficient to ensure laboratory quality—regulatory oversight and proper management systems are more predictive of performance 2.
Supporting Positions to Consider
Beyond the director position, modern laboratories require:
- Project managers to handle ongoing reorganization, consolidation, and automation initiatives that are increasingly common in contemporary laboratory settings 3, 4
- Qualified technical staff whose selection, training, and performance monitoring falls under the director's purview 1
- Quality assurance personnel to support the director's oversight of quality control programs 1
Important Caveat
The complexity of establishing laboratory positions depends heavily on the laboratory type and scope. Physician office laboratories (POLs) may operate with the physician serving as director, though regulated laboratories with dedicated non-doctoral directors consistently demonstrate superior performance compared to unregulated POLs 2. This underscores that proper regulatory oversight and structured management matter more than credentials alone.