Federal Initiatives Related to Nurses and Clinical Laboratory Practice Show
New York State licensed RNs may perform laboratory tests and other laboratory services for their patients pursuant to a valid patient specific order from an authorized prescriber. In addition, RNs may perform HIV and HCV tests, and administer Tuberculosis tests pursuant to a non-patient specific order and protocol issued by a physician or nurse practitioner. New York State Education Law allows an RN to provide these and other nursing related services only if the RN is competent to do so. Finally, an RN may order and perform drug and alcohol screening tests for forensic law enforcement purposes pursuant to the New York State Vehicle and Traffic Law. If there are any follow up questions relating to the practice of nursing or the clinical laboratory technology professions, they should be addressed directly to the Nursing Board office at or the Clinical Laboratory Technology Board at . Questions regarding the regulation and oversight of the clinical laboratories with permits from New York State should be addressed to . Icon for the question 9. Does a person who conducts the ThinPrep process require a license as a certified clinical laboratory technician, or may this be done by an accessioner? Expand CollapseIcon for the answer The ThinPrep process is a high complexity test that requires the operator to be familiar with the laboratory chemical hygiene plan, chemical use and storage, and chemical hazardous material safety knowledge as the reagents used are poisons and flammable liquids. The process requires aseptic technique so specimens are not contaminated with cells from other samples or material that would impact additional testing, such as molecular testing. The process requires judgment by the operator as to when to change the filter between specimens. Though the processing may be a rote procedure, there is potential for significant ability to harm patients and, therefore, the loading of this processor must be performed by a licensed clinical laboratory technology practitioner. Icon for the question 15. May a licensed cytotechnologist perform FISH testing? Expand CollapseIcon for the answer Yes. The statutory language of the scope of practice for cytotechnology includes “and any other such tests,” which can include molecular/FISH testing. However, no cytotechnologist should perform this type of testing and/or engage in this practice if he or she knows or has reason to know that he or she is not competent to do so by education, experience and/or training. Icon for the question 19. Do licensure requirements for Cytoprep Technicians change for processing Pap tests on a T3000 ThinPrep processor, which accepts up to 80 ThinPrep vials? Since the vials are loaded on this processor and prepped automatically, may a non-licensed employee load this processor before a licensed person stains and coverslips the test? Expand CollapseIcon for the answer As noted in the Question and Answers regarding the ThinPrep 2000 (/taxonomy/term/8681), the ThinPrep process is a high complexity test that requires the operator to be familiar with the laboratory chemical hygiene plan, chemical use and storage, and chemical hazardous material safety knowledge as the reagents used are poisons and flammable liquids. The process requires aseptic technique to ensure that specimens are not contaminated with cells from other samples or material that would impact additional testing, such as molecular testing. The process requires judgment by the operator as to when to change the filter between specimens. Though the processing may be a rote procedure, there is potential for significant ability to harm patients and, therefore, the loading of this processor must be performed by a licensed clinical laboratory technology practitioner. Additionally, automated instruments, such as the T2000, T3000, and T5000, are clinical laboratory instruments where many samples are loaded to be processed once the machine is started and as automated instruments and processes continue to be developed for the clinical laboratory, a license as a clinical laboratory technology practitioner is still required for each element of these processes. Moreover, since all analytical automated steps require licensure, non-licensed personnel may not load automated instruments. Which of the following organizations is responsible for the standards for laboratory procedures?The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).
What is CLIA and what is its purpose?What is CLIA? The Clinical Laboratory Improvement Amendments of 1988 (CLIA) is a federal program governed by the Centers for Medicare & Medicaid Services (CMS). Its purpose is to establish quality standards for clinical laboratory testing to ensure that patient test results are accurate and reliable.
What is the meaning of CLIA?The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
What is the purpose of CLIA 88?Congress passed CLIA-88, as a means for the Secretary of Health to develop comprehensive, quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
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Which is a law that mandates the regulations on all facilities who perform patient testing?
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