February 24, 2020Young Wang, MD
CDC states that clinical laboratories performing routine hematology, urinalysis, and clinical chemistry studies and microbiology laboratories performing diagnostic tests on serum, blood, or urine specimens should follow standard laboratory practices, including Standard Precautions when handling potential COVID-19 specimens, in accordance with the Biosafety in Microbiological and Biomedical Laboratories (BMBL), Fifth Edition. CDC has also published the Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for COVID-19. These guidelines state “Clinical specimens should be collected from PUIs for routine testing of respiratory pathogens at either clinical or public health labs. Note that clinical laboratories should NOT attempt viral isolation from specimens collected from COVID-19 PUIs.” Clinical laboratories should consult these two documents for appropriate measures in handling and processing of suspect PUIs specimens.
In order to handle, process, and perform routine testing of respiratory pathogens on potential COVID-19 clinical specimens, clinical and public health laboratories need to have certain lab certification/accreditation in place.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are federal regulations for US-based clinical laboratories that provide industry standards for testing of human samples for diagnostic purposes. These amendments were added to the laboratory requirements outlined in the CFR (Code of Federal Regulations, 42 CFR 493). Three federal agencies are responsible for ensuring compliance of laboratories to CLIA: The Food and Drug Administration (FDA), Centers for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC).
Having a CLIA certificate demonstrates that the clinical laboratory meets the federal regulations for clinical diagnostic testing, ensuring quality and safety in the laboratory and laboratory results. CLIA is a “have to have” clinical lab certification in the US. It is very strong in focused areas including personnel requirements for technical positions, QC requirements for technical specialties/subspecialties, proficiency testing requirements, and enforcement requirements. CLIA-compliant quality management systems address confidentiality, specimen identification, compliant investigation, communication breakdown, lab personnel competency assessments, corrective action and monitoring, procedure manual for pre-examination/examination/post-examination.
Lab accreditation is a type of “nice to have” standard. The two popular accreditation programs are ISO 15189 and CAP (College of American Pathologists). ISO 15189 aligned with ISO 9001 is an internationally recognized accreditation program in clinical lab testing that has been adopted by 160 countries. It outlines strong management system requirements, along with tools and processes needed to stay current with changes and overarching technical requirements. It sets broad standards for best practice in medical laboratories in general and addresses the pre-analytical, analytical and post-analytical processes as a whole in relation to the outcomes. The CAP laboratory accreditation program is an internationally recognized program designed to help clinical laboratories achieve excellence beyond that which is required for regulatory compliance. It is widely recognized as the gold standard, having served as a model for various federal, state, and private laboratory accreditation programs throughout the world.
It is strongly recommended that collection and routine testing of respiratory pathogens, and packaging to ship the potential COVID-19 clinical specimen, be performed in a CLIA-certified laboratory with ISO 15189/CAP accreditation, whether it be a clinical lab, a state or local public health lab, or a Department of Defense lab. Currently, in the US, diagnostic testing for COVID-19 can be conducted only at the CDC.