Calibration Services for Clinical Labs
Clinical and diagnostic laboratories play a vital role in healthcare by conducting various tests and analyses to aid healthcare providers with patient diagnosis, treatment, and monitoring. These laboratories can be categorized based on their primary focus and the types of tests they perform.
For example, clinical chemistry, hematology, microbiology, immunology, serology, molecular diagnostics, anatomic pathology, genomics, and point-of-care testing facilities all require precision in their high-risk applications.
Transcat has the experience to help clinical labs comply with regulations through validation and compliance services tailored to their types of test instruments and custom requirements.
Clinical Lab Instrument Calibration Requirements
Regular instrument calibration is essential to ensure the accuracy and reliability of clinical test results and comply with regulatory standards such as the Clinical Laboratory Improvement Amendments (CLIA). Here are a few common lab process steps requiring calibrated tools and instruments.
- Sample Collection and Handling - Proper collection and handling techniques are crucial to ensure the integrity and quality of the samples. Many specimens, such as blood or microbiology samples, must be stored at specific temperatures during transport. Transcat Temperature Calibration Services support the regulatory requirements for controlling temperature during transit and within the lab. Transcat also offers validation services for incubators, stability chambers, freezers, refrigerators, and cold rooms.
- Specimen Processing - Upon arrival at the laboratory, specimens undergo processing to prepare them for analysis, such as extracting the analytes of interest and removing interfering substances. Transcat instrument validation and calibration services cover common processing instruments, including centrifuges, microscopes, automated analyzers such as chemistry or immunoassay analyzers, automated sample processors, incubators, pipettes, and pH meters.
- Analytic Testing - Instruments used for analytical testing of prepared samples require calibration to ensure proper functioning for accurate and reliable test results. This includes chromatography systems (HPLC, GC), spectrophotometers, dissolution testers, pipettes, pH meters, and moisture analyzers.
- Environmental Monitoring - Instruments used for environmental monitoring within clinical test lab facilities, such as temperature and humidity loggers, particle counters, and air samplers, require calibration for accuracy and compliance. Facilities and equipment calibration documentation is required to prove the traceability of measurements to ISO 17025 laboratory standards.
- Quality Assurance and Compliance - Clinical laboratories adhere to strict quality assurance practices for accreditation, regulatory compliance, and patient safety. This includes conducting proficiency testing, participating in external quality assessment programs, performing regular audits, and maintaining instruments and equipment. NEXA | EAM, a Transcat Company, provides quality management services for laboratory equipment, facilities, and compliance reporting.
Featured Transcat Solutions for Clinical Test Labs
Pipette Calibration and Supplies
Transcat Pipettes offers 3–5-day turnaround for ISO 8655 pipette calibration services and as fast as 24-hour turnaround within defined service areas. We are also a multi-brand distributor of high-quality pipettes, pipette tips, and benchtop equipment.
Commissioning, Qualification, and Validation (CQV) Services
Commissioning, Qualification, and Validation (CQV) Services
The NEXA | EAM team provides CQV services, enabling clients to uphold regulatory compliance, improve operational performance, and ultimately produce reliable and reproducible results. Services range from commissioning and qualification of new processing, analytical equipment, and labs to regulatory inspections and remediations.
Enterprise Asset Management (EAM)
NEXA | EAM, a Transcat Company, provides technical, consulting, and staffing solutions to improve asset management programs for life science industries in North America, Europe, and Asia Pacific. EAM services include calibration, maintenance and spares, reliability, CMMS, quality, compliance, and CQV services.
For more information about our accredited calibration and validation services for clinical test lab equipment, call one of our calibration professionals at 800-828-1470 or contact us.