2005 Rhode Island Code - § 23-16.3-3 — Definitions.

    The following words and terms when used in this chapter have the following meaning unless otherwise indicated within the context:

   (1) "Accredited clinical laboratory program" means a program planned to provide a predetermined amount of instruction and experience in clinical laboratory science that has been accredited by one of the accrediting agencies recognized by the United States department of education.

   (2) "Board" means the clinical laboratory science board appointed by the director of health.

   (3) "Clinical laboratory" or "laboratory" means any facility or office in which clinical laboratory tests are performed.

   (4) "Clinical laboratory science practitioner" or "one who engages in the practice of clinical laboratory science" means a health care professional who performs clinical laboratory tests or who is engaged in management, 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 does not include persons employed by a clinical laboratory to perform supportive functions not related to direct performance of laboratory tests and does not include clinical laboratory trainees. Provided, however, nothing contained in this chapter shall apply to a clinical perfusionist engaged in the testing of human laboratory specimens for extracorporeal functions, which shall include those functions necessary for the support, treatment, measurement, or supplementation 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 established and approved protocols requiring the exercise of independent judgment and responsibility, maintains equipment and records, performs quality assurance activities related to test performance, and may supervise and teach within a clinical laboratory setting.

   (6) "Clinical laboratory technician" means a person who performs laboratory tests pursuant to established and approved protocols which require limited exercise of independent judgment and which are performed under the personal and direct supervision of a clinical laboratory scientist (technologist), laboratory supervisor, or laboratory director.

   (7) "Clinical laboratory test" or "laboratory test" means a microbiological, serological, chemical, hematological, radiobioassay, cytological, immunological, or other pathological examination which is performed on material derived from the human body, the test or procedure conducted by a clinical laboratory which provides information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

   (8) "Department" means the Rhode Island department of health.

   (9) "Director" means the director of the Rhode Island department of health.

   (10) "Limited function test" means a test conducted using procedures which as determined by the director have an insignificant risk of an erroneous result, including those which:

   (i) Have been approved by the United States food and drug administration for home use;

   (ii) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

   (iii) The director has determined pose no reasonable risk of harm to the patient if performed incorrectly.