The persons who are qualified to perform quality control procedures are those
persons specified in the procedure manual for the test. When using a kit method,
quality control should be performed according to the manufacturer's instructions.
When using a method that has been developed by the laboratory itself, the
laboratory director is responsible for establishing quality control parameters and
test performance specifications.
An instrument is calibrated with standards of known levels. An instrument should
be calibrated at a frequency specified by the manufacturer, at least every six
months, whenever the instrument is serviced, or there is a major part change or
reagent change.
6. What are basic personnel license requirements?
People doing testing in California must be licensed, or must work under
supervision of licensed people. Licensure requirements are based on complexity
of testing performed. Before any person works in a laboratory, licensed or not,
their competency to do the job must be documented by the lab director or
technical supervisor.
Doctoral-level people can be licensed as bioanalysts, chemists, microbiologists,
toxicologists, bioanalysts, or genetic molecular biologists. These people can
direct a lab in these specialties, if also licensed by the state as a director, or be
technical supervisors or technical consultants.
Baccalaureate-level people can be licensed as clinical lab scientists, chemistry
scientists, microbiology scientists, hematology scientists, histocompatibility
scientists, genetic molecular biologists scientists, cytogenetic scientists, and
cytotechnologists. These people can work as general supervisors or testing
personnel. A licensed clinical lab scientist can perform tests in all specialties
except cytology or pathology. They can perform phlebotomy and supervise
phlebotomists. Clinical lab specialists, as a clinical hematologist scientist, can
perform testing in all waived and moderate complexity specialties, but can only
perform high complexity testing in their specialty, such as hematology. A
cytotechnologist can only perform cytology testing.
Associate-level people can be licensed as Medical Lab Technicians. MLTs can
perform waived testing without supervision in California and can perform
moderate complexity testing in chemistry, hematology, immunology and
microbiology with supervision. They cannot work in immunohematology (blood
bank) or perform microscopic analyses.
High school-level people can be certified as phlebotomy technicians. Certified
phlebotomists can draw and process blood from patients, but cannot do any
testing.
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