There is an unwritten expectation placed on almost every clinical laboratory manager today: Grow capabilities, scale testing volume, accelerate turnaround times (TAT), and do not break a single thing in the process. During her session at the 2026 Lab Manager Leadership Summit, Stacey Metzler, manager of Clinical Genomics Lab at Phoenix Children’s, noted that this constant tension between rapid clinical demand and the absolute necessity of zero-error quality is the primary domain of operational leaders. This high-pressure environment requires daily, systematic navigation of disruption. But how does a high-complexity laboratory scale operations rapidly without compromising analytical validity, burning out technical staff, or risking accreditation status?
Stacey Metzler, manager, Clinical Genomics Lab at Phoenix Children’s.
In her session, Metzler reiterated that Phoenix Children’s clinical genomics laboratory navigated this exact challenge. Over a remarkably short timeline, the laboratory transitioned from a young, homegrown facility into a top-tier pediatric genomics program. This journey demonstrated that scaling lab operations successfully is not just about procuring high-throughput sequencers or faster bioinformatics pipelines. True laboratory management excellence centers on building resilient workflows, decoupling clinical and operational management, designing the entire pre-to-post-analytical ecosystem, and scaling lab operations efficiently.
A practical blueprint for laboratory expansion exists to guide operational leaders through rapid, high-stakes growth.
Case study: the Phoenix Children's journey
Managing rapid growth effectively requires analyzing how quickly an operational landscape can shift. Founded in 2017, the clinical genomics laboratory at Phoenix Children's was established as a high-complexity facility accredited through the College of American Pathologists (CAP) Laboratory Accreditation Program— which also satisfies federal requirements under the Clinical Laboratory Improvement Amendments (CLIA)—built from the ground up. By 2019, the laboratory established first-tier testing, primarily chromosomal microarrays, to serve a high-volume patient population presenting with developmental delays and congenital anomalies.
By 2022, next-generation sequencing (NGS) had just launched, but the operation quickly hit a major technological wall. The NGS workflow relied on a homegrown bioinformatics pipeline that capped clinical analysis at a 4,000-gene backbone. During the presentation, Metzler explained that the initial homegrown pipeline "was not built to scale," capping critical database potential.
Active engagement in "customer development"—consulting directly with ordering physicians to assess clinical utility—revealed that a 4,000-gene panel was insufficient to meet clinical needs. Providers required a clinical exome covering all 20,000 genes to prevent diagnostic delays.
This gap created a daunting operational crossroads. Navigating this transition required securing executive leadership support to decommission the homegrown pipeline and obtain capital for an upgrade. Metzler recounted having to seek executive alignment to completely replace the framework, stating, "Everything we've built, we need to scrap." Within a grueling 12-month window, the laboratory partnered with leading biotechnology developers, upgraded the bioinformatics pipeline, and launched rapid clinical exome and whole-genome sequencing for critically ill inpatients—a complex process requiring meticulous equipment procurement and validation planning.
Every iteration of this rapid evolution brought intense pressure across four main pillars: staffing, technology, volume, and regulatory compliance. Managing this pressure successfully requires a structured, strategic approach designed specifically for the laboratory management level.
Demarcating clinical versus operational management
In a small or expanding laboratory, leadership roles often blur. It is common for medical directors (PhDs, MDs) and laboratory managers to experience significant overlap in daily responsibilities. While effective in small-scale settings, this lack of structure creates massive friction during growth and hinders long-term laboratory expansion.
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To scale successfully, clear lanes of accountability must be established:
- The Clinical and Scientific Arm: This branch is responsible for establishing clinical utility and designing validation frameworks. It also sets technical assay requirements to meet medical needs, interprets complex variants, and signs off on clinical reports.
- The Operational and Management Arm: This branch is responsible for designing daily workflows, managing the supply chain, and monitoring reagent inventory. It also handles full-time equivalent (FTE) logistics, maintains instrument uptime, and engineers systems that support clinical decisions consistently.
When these boundaries are unclear, misalignment occurs. External and internal stakeholders lack a clear channel of communication, and the laboratory begins to rely on individual heroics rather than standardized systems.
The danger of tribal knowledge and single-point failures
If a laboratory is "one resignation away from total failure," a scalable system does not exist—only an acute operational risk. Metzler warned against over-reliance on tribal knowledge, urging leaders to avoid this single point of failure. When crucial process steps—such as specific instrument calibrations, laboratory information system (LIS) troubleshooting, or sample preparation nuances—exist only in a single technician's memory, unexpected staff turnover creates an immediate bottleneck.
To prevent this, a clinical laboratory manager must proactively document standard operating procedures (SOPs), cross-train technical staff aggressively, and establish baseline quality metrics, such as TAT and analytical error rates, long before adding volume to the system.
Balancing the triad: speed, capacity, and technical well-being
In clinical diagnostics, turnaround time is often the key metric of success. Transitioning to rapid whole-genome sequencing reduced turnaround times from a standard four to six weeks to preliminary results within days.
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However, pushing for speed without aligning staff capacity is a direct path to technical errors, SOP deviations, and staff burnout. Metzler highlighted that fast turnaround times can cause issues if capacity is lacking, noting, "If you don't have the staff and you don't have the workload to support it, you will have rework and you will have burnout."
Monitoring the true warning signs of overcapacity
Monitoring data-driven key performance indicators (KPIs) like tests per labor hour and overtime trends is essential. However, some of the most critical warning signs are behavioral.
When top-performing technicians—personnel who are normally highly engaged and vocal in department meetings—suddenly remain quiet, that silence acts as an operational red flag. This may indicate that change fatigue has set in, and the laboratory floor is struggling to keep pace with the demands of scaling lab operations.
To maintain capacity and protect technical well-being without overwhelming staff, lab managers must:
- Acknowledge the Operational Burden: Management must demonstrate active appreciation, even though clinical laboratory work is deeply mission-driven. Maintaining open communication, addressing workstation ergonomics, and advocating for adequate FTE support at the executive level are vital components of sustainable laboratory management.
- Introduce Self-Tracking and Time-Studies: Rather than implementing top-down micromanagement, laboratory managers can provide technicians with simple time-tracking tools. Documenting daily tasks for a two-week period helps identify exactly where operational delays occur, such as manual aliquoting, a cumbersome LIS interface, or delays in specimen delivery. This approach respects professional autonomy while yielding highly accurate bottleneck data to prevent the profitability paradox of thriving labs with exhausted workforces.
- Involve Bench Technicians Early: Comprehensive workflow design should not be executed in an executive vacuum. Metzler emphasized the importance of early staff engagement by recounting direct, candid feedback from bench technicians when a workflow design fell short.
Building the entire ecosystem, not just the wet lab assay
When launching a new molecular or diagnostic test during a laboratory expansion, attention often focuses entirely on wet lab validation—the pipetting, the robotics, the chemistry. But in practice, the analytical test itself is often the easiest part to execute successfully.
What actually determines a successful launch is the operational architecture built around the test. Failure to establish pre-analytical and post-analytical workflows in parallel with assay validation will cause the project to fail at the starting line.
Before going live, a thorough walkthrough of the entire specimen journey must address several critical factors:
- Laboratory Information System (LIS) and EHR Integration: The test must be easily orderable within the electronic health record systems clinicians use daily. If ordering requires navigating complex external portals or manual paper requisitions, clinicians will likely bypass the in-house offering and continue sending samples to external reference laboratories out of habit.
- Pre-Analytical Logistics and Billing: Process plans must dictate when patient consent is obtained and how insurance prior authorization is handled. If CPT codes and billing pathways are not aligned with finance and revenue integrity prior to launch, the laboratory risks catastrophic charge-capture failures that severely damage financial performance.
- Technology Paradox: Automation and digital tools are highly effective for analytical scaling, but these solutions rarely solve pre-analytical bottlenecks. A state-of-the-art analytical engine still requires physical hands to route specimens, scan barcodes, and verify labels. Software upgrades cannot resolve physical pre-analytical logistics gaps on the receiving dock. Managing relationships with external providers was highlighted as another key operational challenge, as Metzler noted that vendors "are not accountable really to uphold the same expectations on project launch timelines" as internal management teams.
Integrating quality assurance into the build
A common mistake in expanding laboratories is treating quality assurance (QA) as a final checklist—something to address immediately prior to a CAP inspection or an inspection under the Clinical Laboratory Improvement Amendments (CLIA) program to ensure regulatory standards are met for patient safety.
To scale safely, QA must be an active partner integrated directly into the initial workflow design, rather than tacked on at the end.
The power of the "controlled launch"
When rolling out the rapid exome and genome sequencing program, management resisted the urge to open ordering to the entire hospital system on day one. Instead, the team executed a highly controlled pilot.
Initial ordering privileges were limited to a small, specific subset of providers: neonatal intensive care unit (NICU) clinicians. These infants represented the patient population benefiting most from rapid, comprehensive genomic testing. Crucially, this small cohort of providers was highly engaged, understood the pilot nature of the workflow, and provided active feedback.
Starting small allowed the laboratory to stress-test specimen logistics, LIS reporting, and billing pathways in a live but controlled environment. Identifying and correcting minor operational friction points prior to system-wide expansion protected the laboratory's clinical reputation and built invaluable institutional trust.
The quiet power of lab operations
Scaling a clinical laboratory is an exercise in managing perpetual adaptation. This process requires laboratory managers to possess a "quiet power"—the ability to stay calm under intense pressure, shield technical staff from systemic chaos, and methodically build robust systems rather than relying on unsustainable individual efforts.
In closing the presentation, Metzler defined operational leadership as a "quiet power," warning against unsustainable growth: "To collapse is one thing, to build something and then it fizzles out because it doesn't work in practice." To guide leaders through these complex challenges, Metzler offered a final piece of advice: "Keep your patience at the center for all your decisions."
Clearly separating clinical and operational roles, protecting laboratory bandwidth, designing a comprehensive pre-analytical ecosystem, and partnering with QA from day one enables successful scaling of laboratory capabilities. This strategic approach secures the laboratory's position as a top-tier clinical partner, ensuring that no matter how fast operations expand, the patient at the center of every specimen remains the primary focus.
