In the U.S., the Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans (except research) through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing. Macrogen Corp. has received CLIA certification from U.S. CMS and provides CLIA-quality whole exome sequencing.
Macrogen Corp. performs routine quality management procedures, including laboratory conditioning and equipment and instrument validation, to guarantee high quality of data. Macrogen Corp. also performs QC (quality control) with higher standards, where all laboratory procedures are processed by certified personnel only.
Safety
- Restricted laboratory access
- CLIA-level technical processes
- Secure & Protected Data
- Secure on-site server analysis
Enhanced Analysis
- <ahref=”http://macrogenlab.com/hereditary-diseases/”>Customized analysis for various hereditary diseases and cancers
- Project consultation about clinical genomic research
- Clinical service advice
Quality
- CLIA-level, high quality data (accurate and precise)
- Strict & Regular quality control
- Frequent calibration and validation
CLIA Regulations
CLIA regulates all processes within the laboratory for accurate and consistent clinical sequencing results. In recent years, changes to CLIA have been implemented to provide patients with greater access to their laboratory results.
Standards for Extracting DNA from Blood and Saliva
Blood collection is considered the gold standard for DNA quality. However, saliva collection is fast, non-invasive and easy to collect. CLIA standards specify that saliva DNA must perform equivalently in downstream applications to that of blood in order for saliva collection to meet CLIA regulations. To ensure accurate and precise data, Macrogen implements the following procedures:
- CLIA-level, high-quality data compliance
- Strict and regular quality control measures
- Regular calibration and validation
Secured Data Transfer
The final rulings on CLIA regulations specify that a patient, patient representative or person designated by the patient have made available copies of completed test reports, that through the laboratory’s authentication process, can be identified as belonging to that patient. Other safety measures Macrogen includes are:
- Restricted laboratory and equipment access
- CLIA-level technical processes
- Secure and protected data
- Secure on-site server analysis
HIPAA Compliance
In 2014, the U.S. Department of Health and Human Services amended privacy regulations of the CLIA of 1998 regulations and the Health Insurance Portability and Accountability Act (HIPAA) of 1996. These amendments gave patients and their personal representatives access to laboratory test results, empowering patients to take an active role in managing their health and health care.
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