CDC Laboratory Information Management System (LIMS)

During public health emergencies, the volume of test samples grows exponentially (e.g., nucleic acid and antibody tests), making traditional manual recording and paper-based processes inadequate in meeting timeliness and accuracy requirements. There is a need to integrate multi-source data (such as sample information, test results, and personnel tracking) and interface in real-time with disease control centers, hospitals, and government platforms. Traditional systems suffer from information silos. Shengyuan Guangtong’s Epidemic Control Center Laboratory Testing LIMS system builds an intelligent ecosystem covering the entire chain from sampling, transportation, testing, to reporting. It has gradually evolved into the central nervous system of the public health system, capable of automatically detecting abnormal data fluctuations. Test results must comply with international/national standards (e.g., ISO 15189), and full-process traceability has become a regulatory necessity.

System Architecture

Business Process

I. Business Acceptance and Contract Management

Business Acceptance: Supports multi-channel submission of testing requests (e.g., online platforms, phone, on-site), automatically generating unique business numbers.

Contract Review: Multi-department collaborative review (e.g., legal, technical, financial), recording review comments and revision versions.

II. Full Lifecycle Sample Management

Sample Registration and Barcode Scanning: Uses barcodes/QR codes for unique sample identification, automatically linking testing items and standards.

Sample Management: Tracks sample status (e.g., pending testing, in testing, retained, destroyed), integrates temperature and humidity monitoring with anomaly alerts.

III. Testing Tasks and Quality Control

Task Assignment: Intelligent assignment based on personnel qualifications, equipment status, and task priority, with support for manual adjustments.

Result Entry and Review: Supports automatic data interface between LIMS and instruments; result entry requires dual-person, dual-position review.

IV. Report Approval and Output

Multi-level Review: Department review → Report review → Report approval, supports electronic signatures and version traceability.

Report Generation and Distribution: Supports export in PDF/Word formats.

V. System Integration and Scalability

System design complies with ISO/IEC 17025, adopts three-level security standards, encrypts data storage and transmission, supports audit trails, mobile compatibility (e.g., PAD for on-site sampling), and AI assistance (e.g., OCR for sample label recognition). Establishes a 7×24 technical support system.

Laboratory Sampling

I. Sampling Plan and Task Management

Sampling Plan Development: Supports automatic generation of sampling plans by disease type (e.g., infectious diseases, occupational diseases), region (GIS heatmap analysis), and time cycle (e.g., weekly/monthly monitoring). The system automatically adjusts sampling density (e.g., daily sampling in high-risk areas, weekly in low-risk areas).

Sampling Task Assignment: Intelligent task allocation based on personnel qualifications (e.g., sampling certification, protection level), equipment status (e.g., sampling tube inventory, cold chain transport capacity), and transportation costs (GIS route planning).

Rule Engine: Prioritizes assigning the nearest sampling personnel to sampling points; high-risk sampling tasks automatically match technicians with BSL-3 qualifications; automatic alerts for task conflicts (e.g., a sampler’s daily task overload).

II. On-site Sampling Execution

Online Sampling Information Entry: Sample name, quantity, source unit, sampling time, storage conditions (e.g., -20°C), sample status (e.g., normal/damaged).

Sampling Results and Equipment Usage Records: Supports on-site entry of preliminary test results (e.g., rapid test strip results) and links to equipment used (e.g., sampling swab brand, model, expiration date).

Electronic Signatures and Photos: Samplers and accompanying personnel provide handwritten signatures via mobile devices, with timestamps automatically embedded. Supports multi-angle photos (e.g., sample appearance, environmental conditions, equipment status), with photos automatically linked to sampling records.

GIS Positioning and Track Playback: Automatically captures GPS coordinates during sampling, generating sampling trajectory maps; supports historical track playback for auditing.

III. Quality Control and Compliance

Dual-Person, Dual-Position Mechanism: Sampling result entry requires dual confirmation; the system automatically compares entered values with on-site photo results.

Compliance Checks: Automatically verifies if sampling procedures comply with standards (e.g., wearing protective equipment, completing disinfection).

IV. Key Technical Implementation Points

Mobile Compatibility: Supports iOS/Android, compatible with PADs, phones, and other devices. Offline operation supported in poor network conditions, with automatic data synchronization upon reconnection.

V. Collaborative Management and Emergency Response

Internal Collaboration: Establishes multi-disciplinary collaboration mechanisms (e.g., joint investigations by epidemiology, microbiology, and toxicology during foodborne disease outbreaks).

External Collaboration: Data exchange with market supervision, ecological environment, education, and other departments (e.g., sharing school health test results). Participates in regional public health emergency coordination (e.g., rapid response during public health emergencies).

Laboratory Comprehensive Management

Personnel Management: Establishes a multi-level, multi-format training system including pre-job training, continuing education, and skill enhancement to improve the professional quality and operational skills of laboratory personnel. Implements strict assessment systems, regularly testing theoretical knowledge and practical skills to ensure competency. Implements hierarchical permission management, assigning different operational rights based on roles and responsibilities to prevent unauthorized operations and data leaks.

Instrument and Equipment Management: Maintains equipment archives recording the entire lifecycle from procurement, acceptance, use, maintenance, repair, to decommissioning. Regularly calibrates and maintains instruments to ensure optimal performance and accuracy of test results.

Reagent and Consumable Management: Implements management systems for procurement, acceptance, storage, use, and disposal of reagents and consumables to ensure quality and compliance. Uses inventory alerts to timely replenish stocks, avoiding disruptions due to shortages.

Hazardous Chemical Management: Integrates with smart reagent cabinets, smart locks, balances, access control videos, temperature and humidity sensors, and other smart hardware devices. Records and manages laboratory hazards, safety risks, safety facilities, and safety training. Ensures compliance with safety requirements throughout the storage, use, disposal, and "dual-person, dual-lock" management of chemicals via comprehensive, detailed oversight.

Sample Identification: The system automatically compares sampling plans and commission orders, verifying consistency in sample name, ID, quantity, etc. Uses barcode or QR code technology to assign unique codes to each sample, linking detailed information such as source, collector, collection time, and test items to prevent sample mix-ups.

Report Management: Develops unified report templates for different testing areas (e.g., food, environment, pathogenic microorganisms), specifying format requirements for key elements like test items, methods, results, and conclusions. Implements a three-level review mechanism (tester, reviewer, approver) to ensure report accuracy and compliance. Uses electronic signatures for tamper-proofing and traceability, supporting online query and download. Dynamically adjusts task priority based on urgency (e.g., public health emergencies vs. routine monitoring) to ensure timely issuance of critical reports. Conducts dual-person review of key data (e.g., pathogenic bacteria results, heavy metal exceedances) to ensure accuracy.

Statistical Analysis: Supports multi-dimensional data querying and statistical analysis, summarizing test data to calculate means, medians, standard deviations, and other statistics to reveal data distribution characteristics. Combines test results with risk level standards to assess public health risk levels, categorizing high, medium, and low-risk areas or groups. Visualizes data through charts, maps, and other forms to intuitively present analysis results and aid decision-making.