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Are there CLIA defined qualifications for the directors of waived laboratories?

For waived testing, there are no federally defined qualifications for the Laboratory Director in the Clinical Laboratory Improvement Amendments (CLIA). The individual should have the technical knowledge and experience required to oversee the specific laboratory testing performed.

What are the qualifications for a 493.1405 standard laboratory director?

493.1405 Standard; Laboratory director qualifications. The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part.

Can a PhD be a CLIA lab director?

Most states do not have specific requirements for the qualifications of Lab Directors overseeing Waived testing; however, CA, HI, IL, MD, MA, NV, NJ, NY, PA, and TN do require the CLIA Director of Waived testing to possess certain credentials, and these state qualification standards range from an Associates Degree to

What is the role of a laboratory director in CLIA?

The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations.

What is a chief director of a laboratory?

A Laboratory Director is responsible for overseeing all laboratory operations, including staff, resources, and testing services. They are responsible for developing strategies for achieving the laboratorys goals and objectives, as well as setting policies and procedures for quality assurance and safety.