Questions & Answers
Practice of Clinical Laboratory Technology Professionals
Two recent federal initiatives (described below) have caused concern among some professionals in New York.
- The federal Department of Veterans Affairs (VA) proposed a regulation to allow Advanced Practice Registered Nurses to supervise and perform laboratory tests in VA laboratory facilities. New York State does not regulate VA laboratory facilities or VA laboratory staff.
- The Centers for Medicare & Medicaid Services (CMS) indicated that that Clinical Laboratory Improvement Act (CLIA) allows RNs with BSNs to perform moderate and high complexity laboratory tests and RNs with ADNs to perform moderate complexity tests. CLIA does not apply to New York State Clinical Laboratories or to any staff who work for these laboratories. Federal Law specifically allows New York State to regulate New York State Clinical Laboratories in accordance with New York State Law.
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 email@example.com or the Clinical Laboratory Technology Board at firstname.lastname@example.org. Questions regarding the regulation and oversight of the clinical laboratories with permits from New York State should be addressed to email@example.com.
- Should a license be required for individuals doing the initial set-up or plating of microbiology specimens? Can laboratory aides perform the pre-analytic steps?
The initial set-up or plating of microbiology specimens requires the selection of appropriate media for the specimen type. The adequacy of specimen collection, transport temperature, the recognition of special culture requirements, optimal streaking for isolation of colonies and the gram staining preparation require, in part, both the possession of a certain body of professional knowledge and its application. At times, a gram stain must be done. The degree of knowledge needed by those who perform this task falls, at least, at the technician level. Therefore, laboratory aides should not perform these pre-analytic steps.
- As automated instruments and processes continue to be developed for the clinical laboratory, is a license as a clinical laboratory technology practitioner required for each element of the process when using such automated instruments?
In using an instrument, a clinical laboratory technology practitioner is necessary for all automated steps, including pre-analytic steps, if the steps require professional judgment and/or decision-making.
Since all pre-analytical and analytical automated steps involve professional judgment and/or decision-making, they must be performed by a clinical laboratory technology practitioner. Therefore, non-licensed personnel may not load instruments. Licensure is required when staff interact with patient specimens because there must be a record of the chain of custody for all specimens and the persons receiving them must know that they have been properly handled.
In addition, when sophisticated state of the art instruments and/or equipment break down and/or fail to function correctly, the troubleshooting of such situations becomes the responsibility of the clinical laboratory technology practitioners.
- There are many different aspects of preventive maintenance (PM). Some are more technically driven than others. For example, a monthly scheduled PM is different than the daily set-up that includes reagent handling. Who may perform preventive maintenance or a daily instrument set-up?
Performing annual or monthly equipment maintenance is often considered a manufacturer’s responsibility that could be performed by those trained to do so, and such persons often would not be clinical laboratory technology practitioners. A daily instrument setup would be the ultimate responsibility of the clinical laboratory technology practitioners, as a part of their initial quality assurance process, to ensure that the instrument was functioning properly prior to the testing of patient specimens.
- Is it within the scope of practice for clinical laboratory technology practitioners working in the area of hematology to perform differential microscopic examinations of bone marrow smears?
Since bone marrow cells are included in hematology, clinical laboratory technology practitioners could perform microscopic differential examinations for preliminary screening, but final review and result reporting is the responsibility of the pathologist.
- Is a clinical laboratory technologist or certified clinical laboratory technician able to adjust Coumadin levels with “standing orders” from a physician in a “Family Practice Coumadin Clinic?”
No. This is not in the scope of practice of clinical laboratory technologists or certified clinical laboratory technicians.
- In our setting, we have two clinical laboratory technologists and one phlebotomist. All are proficient with venipuncture. Would placing venous access devices (an angiocatheter attached to a saline lock) be within their scope of practice?
A phlebotomist is not a licensed practitioner and does not have a statutory scope of practice. A phlebotomist would not be authorized to place a venous access device, as described. Placing venous access devices is not within the scope of practice of the clinical laboratory technologists.
- Do phlebotomists that do platelet counts for donor/component assessment need to be licensed?
Yes. Platelet testing is performed by an automated instrument although there are times, e.g., low platelet counts, when the test is performed manually in a hemocytometer. Control samples are performed as part of the QC, and calibration is also performed as necessary. This requires a licensed individual.
- Do individuals who perform testing to qualify blood donors need to be licensed?
Tests performed as part of the qualifying process for blood donor screening, such as hematocrit determination, may not require a licensed individual. Most of these are waived tests and are considered exempt under the federal law and New York State Public Health Law. The regulation of waived testing sites falls under the regulation of the New York State Department of Health, and questions related to waived testing sites should be directed to the Department of Health at CLEP@health.ny.gov.
- 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?
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.
- May a cytotechnologist assist in fine needle aspiration biopsy procedures in radiological suites? May the cytotechnologist provide a rapid interpretation of the specimen so that the radiologist could immediately move to oblation therapy?
Cytotechnologists may assist in the radiological suite by preparing the cytological smear, rapidly staining the slide(s) and making a rapid determination of the adequacy of each needle puncture sample. The radiologist uses this information to determine if another puncture is required for assessment of the lesion or target in question. The cytotechnologist is prohibited by CLIA and the New York State Department of Health regulations from providing a preliminary interpretation or diagnosis, as all non-gynecological specimens must be reported by a pathologist.
- May laboratory assistants collect throat cultures from patients and inoculate patient microbiology specimens onto transport and growth media, e.g., placing swabs in viral transport media or fungal transport media?
Laboratory assistants may not collect throat cultures. Laboratory assistants may not inoculate patient microbiology specimens onto transport and growth media, e.g., placing swabs in viral transport media or fungal transport media. Clinical laboratory technology practitioners may accept cultures from professionals authorized to collect them, but may not collect throat cultures.
- Should a license be required for individuals performing bleeding times? Can phlebotomists perform this?
This test is classified as a test of moderate complexity and may not be done by a phlebotomist.
- Some licensure-qualifying, registered programs in cytotechnology now usually include the study of molecular cytology and diagnostic technology. May cytotechnologists include molecular technology tests and procedures within their practice?
Cytotechnologists may include the molecular cytology and diagnostic technology tests and procedures that are taught in the licensure-qualifying programs in cytotechnology. Education Law Section 8601(2)(b) defines "Cytotechnologist" to mean "a clinical laboratory practitioner who, pursuant to established and approved protocols of the Department of Health, performs cytological procedures and examinations and any other such tests including maintaining equipment and records and performing quality assurance activities related to examination performance, and which require the exercise of independent judgment and responsibility, as determined by the department." Licensees must know that they are competent to perform such procedures before doing so. In addition, the laboratory must be qualified by the New York State Department of Health to perform the procedure on the specimen.
- May a licensed clinical laboratory technology practitioner place the frozen section specimen in the Cryostat, cut the specimen, make and stain the slide for the pathologist to perform the professional component?
Yes, a person licensed as a certified histological technician may operate a Cryostat and stain frozen sections, which are then interpreted by a pathologist. This process may also be done by a person licensed as a clinical laboratory technologist or a certified clinical laboratory technician. However, a clinical laboratory technology practitioner should not perform or provide a service that he or she knows or has reason to know that he or she is not competent to provide or perform.
- May a licensed cytotechnologist perform FISH testing?
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.
- Would a licensed cytotechnologist be able to perform karyotype and microarray testing, which are other tests performed in the Cytogenetics laboratory?
The practice of performing karyotype and microarray testing, commonly done in a cytogenetics laboratory, falls in the broad practice for those licensed as clinical laboratory technologists. The clinical laboratory technology statute provides for a restricted license in cytogenetics, which a licensed cytotechnologist would also need to hold in order to perform these tests. However, no clinical laboratory technology practitioner 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.
- Could a frozen specimen obtained by a radiologist be handed off to non-licensed tissue procurement personnel to be stored in a freezer until it needs to be retrieved for molecular studies?
Specimens only requiring transport would not fall under the restrictions of the scope of practice of the clinical laboratory technology practitioner. Additionally, the identification of the sample is the responsibility of the person obtaining the sample, or the person who has been delegated to handle this activity.
- What are the regulatory requirements to perform grossing procedures?
Grossing personnel must possess a license, such as, but not limited to, a physician or clinical laboratory technology practitioner license, or be otherwise authorized in statute or regulation to engage in the grossing process.
- 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?
As noted in the Question and Answers regarding the ThinPrep 2000 (www.op.nysed.gov/prof/clt/clpques-ans.htm), 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.
- Is a licensed practitioner required to coverslip the microscopic slide or may this be done by an assistant?
A license as a clinical laboratory technology practitioner is needed to coverslip the microscopic slide to ensure specimen integrity.