§ 23-16.3-3 - Definitions.
SECTION 23-16.3-3
§ 23-16.3-3 Definitions. The following words and terms when used in this chapter have the followingmeaning unless otherwise indicated within the context:
(1) "Accredited clinical laboratory program" means a programplanned to provide a predetermined amount of instruction and experience inclinical laboratory science that has been accredited by one of the accreditingagencies recognized by the United States Department of Education.
(2) "Board" means the clinical laboratory science boardappointed by the director of health.
(3) "Clinical laboratory" or "laboratory" means any facilityor office in which clinical laboratory tests are performed.
(4) "Clinical laboratory science practitioner" or "one whoengages in the practice of clinical laboratory science" means a health careprofessional who performs clinical laboratory tests or who is engaged inmanagement, education, consulting, or research in clinical laboratory science,and includes laboratory directors, supervisors, clinical laboratory scientists(technologists), specialists, and technicians working in a laboratory, but doesnot include persons employed by a clinical laboratory to perform supportivefunctions not related to direct performance of laboratory tests and does notinclude clinical laboratory trainees. Provided, however, nothing contained inthis chapter shall apply to a clinical perfusionist engaged in the testing ofhuman laboratory specimens for extracorporeal functions, which shall includethose functions necessary for the support, treatment, measurement, orsupplementation of the cardiopulmonary or circulatory system of a patient.
(5) "Clinical laboratory scientist" and/or "technologist"means a person who performs clinical laboratory tests pursuant to establishedand approved protocols requiring the exercise of independent judgment andresponsibility, maintains equipment and records, performs quality assuranceactivities related to test performance, and may supervise and teach within aclinical laboratory setting.
(6) "Clinical laboratory technician" means a person whoperforms laboratory tests pursuant to established and approved protocols whichrequire limited exercise of independent judgment and which are performed underthe personal and direct supervision of a clinical laboratory scientist(technologist), laboratory supervisor, or laboratory director.
(7) "Clinical laboratory test" or "laboratory test" means amicrobiological, serological, chemical, hematological, radiobioassay,cytological, immunological, or other pathological examination which isperformed on material derived from the human body, the test or procedureconducted by a clinical laboratory which provides information for thediagnosis, prevention, or treatment of a disease or assessment of a medicalcondition.
(8) "Department" means the Rhode Island department of health.
(9) "Director" means the director of the Rhode Islanddepartment of health.
(10) "Limited function test" means a test conducted usingprocedures which as determined by the director have an insignificant risk of anerroneous result, including those which:
(i) Have been approved by the United States Food and DrugAdministration for home use;
(ii) Employ methodologies that are so simple and accurate asto render the likelihood of erroneous results negligible; or
(iii) The director has determined pose no reasonable risk ofharm to the patient if performed incorrectly.