Questions & Answers
Practice of Clinical Laboratory Technology Professionals
- 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 a certain body of professional knowledge and its use. 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?
Yes. All analytical automated steps require licensure. Non-licensed personnel may not load instruments.
- 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 technologists. A daily instrument setup, including reagent handling, could be performed by a trained laboratory assistant, but it would be the responsibility of the clinical laboratory technologists, as a part of their initial quality assurance process, to ensure that the instrument was functioning properly prior to testing of patient specimens.
- Is it within the scope of practice for clinical laboratory
technologists 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 technologists 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
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.state.ny.us.
- Does a person who conducts the Thin Prep process require
a license as a certified clinical laboratory technician, or
may this be done by an accessioner?
The Thin Prep 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 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 must, therefore, be performed by a licensed clinical laboratory 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 technologists 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 much 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.