Due to the high degree of specificity in cytogenetic testing, a number of certifications and accreditations are required for facilities to operate properly. Compliance for some of these certifications is required by federal law, while adherence to others simply indicates a testing facility’s commitment to excellence and continued learning.
The Clinical Laboratory Improvement Amendments (CLIA) Certification is one of XX designations require by law and has as its objective to ensure quality laboratory testing. Below is a look into some of the details of CLIA Certification, revealing its importance to cytogenetic lab testing.
Despite the fact that the CLIA Certification is entering its thirtieth year in existence, it remains one of the most important credentials in the laboratory testing space. Over the course of nearly three decades, the original CLIA regulations established in an amendment to the Public Health Service Act of 1988 have acquired more than 130 amendments to bring its statutes in line with current technologies and to reflect best practices around laboratory testing.
The task of implementing CLIA Certification standards falls to the Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality (CCSQ). This body, along with all cytogenetic laboratory testing, is regulated by the Centers for Medicare and Medicaid Services (CMS). In all, according to CMS, CLIA standards ensure quality testing at approximately 254,000 laboratory entities in the United States.
To become CLIA certified, applicants must fill out the CMS-116 application and submit it to their state CMS agency. Once processed, their testing facility will receive an invoice for a one-time fee. When that fee is paid in full, CMS will mail the CLIA certificate. Some states require additional state licensure for clinical laboratories. Arizona, on the other hand, requires only that laboratories carry CLIA Certification. Make sure to familiarize yourself with the regulations governing laboratory operation in your region.
Outsourcing your cytogenetic testing is also a very common industry practice. Virtual Scientific can save your business valuable time and money by conducting your cytogenetic testing needs. Our laboratories and technologists have all the certifications and accreditations mentioned in the article above so that your workflow can stay intact, no matter the testing application. Virtual Scientific clients benefit from our industry-leading TAT, and our highly experienced cytogenetic technologists integrate into your team seamlessly, adapting easily to different analysis protocols.
Contact Virtual Scientific today to learn more, or take our free assessment to learn how you can grow your testing capacity and improve your bottom line by partnering with us.