Facility Planning & Zoning
- Unidirectional flow: Receipt → extraction → amplification/detection → post-amp; minimize backtracking and aerosol risk
- Clean/dirty separation: Physically separate pre-amp and post-amp spaces; dedicated PPE and consumables
- HVAC & biosafety: Pressure differentials where required; BSC-II for high-risk matrices; validated waste handling
- Utilities & layout: Power, network, UPS, bench depth, and ergonomic placement to reduce handling errors
Method Verification/Validation (Per Matrix)
- LoD determination: Serial dilutions around decision thresholds for each target/matrix
- Inclusivity/Exclusivity: Circulating strains and near-neighbors to quantify cross-reactivity risk
- Precision/Reproducibility: Inter-day, inter-operator, inter-instrument studies with acceptance criteria
- Carryover & contamination: High-positive next to negatives; enforce unidirectional workflow, dUTP/UNG where applicable
- Interference: Blood, mucus, medications, preservatives; define re-test policies and dilution strategies
- Stability: Time/temperature studies to support logistics and site-to-site transport
Quality System (QMS) Build-Out
- SOP suite: Collection/transport, accessioning, extraction, amplification, result review, reporting, incident response
- Qualification templates: IQ/OQ/PQ for instruments; periodic maintenance and calibration logs
- EQA/PT enrollment: Program selection, performance trending, and CAPA for deficiencies
- Change control: Reagent lots, software/firmware, database versions; documented risk assessments before go-live
- KPIs: Inhibition rate, invalid/repeat rate, control Ct drift, contamination events, TAT, corrective action closure time
Training & Competency
- Wet-lab skills: Pipetting accuracy, contamination control, inhibitor troubleshooting, correct use of controls
- Data analysis: Threshold logic, co-detection interpretation, differentiation of colonization vs. infection
- Clinical interpretation workshops: Align report language with infectious-disease and stewardship teams
- Annual competency: Scenario-based assessments; refresher modules after method or software changes
Go-Live Roadmap (Condensed)
- Site survey & layout with zoning plan and equipment list
- Install & qualify instruments (IQ/OQ/PQ)
- Author & train on SOPs; simulate end-to-end runs with controls
- Execute validation (LoD, inclusivity/exclusivity, precision, interference, stability)
- EQA/PT signup and initial cycles
- Soft launch with parallel testing; finalize reporting templates and escalation pathways
- Full go-live with KPI dashboards and weekly quality huddles
Turnkey Molecular Lab Solutions: Zoning, Validation, QMS, Training
Turnkey solutions compress time-to-service while building a sustainable, audit-ready operation. With zoning, validation, QMS, and training aligned from day one, the lab delivers consistent, same-day results and adapts smoothly to seasonal surges, outbreaks, and method updates.