105 CMR, § 180.010
In 105 CMR 180.000 the following words shall, unless the context requires otherwise, have the following meaning:
Accredited means the approval of schools, institutions, or programs, where appropriate, by a nationally recognized accrediting agency or association as determined by the U.S. Commissioner of Education, or, on an equivalent basis by the Department.
Approved Clinical Laboratory means a clinical laboratory with a director at the level required by M.G.L. c. 111D § 7; or a director at the level of a hospital, a health department, university, medical research institution or military institution of the United States Government; or, a clinical laboratory certified under 42 C.F.R. 405.1310et seq.: Subpart M. Conditions for Coverage of Clinical Laboratories; or a clinical laboratory licensed under the Clinical Laboratories Improvement Act of 1967; or a laboratory providing equivalent training or experience accepted by the Department.
Clinical Laboratory means a facility or place, however named, the purpose of which is to make biological, serological, chemical, immunohematological, cytological, pathological, or other examinations of materials derived from a human body.
Collection Station means a facility where materials orspecimens are either withdrawn or collected from patients or assembled after being withdrawn of collected elsewhere from patients for subsequent delivery to a clinical laboratory for examination. A collection station is a facility which is maintained at a separate physical location not on the grounds or premises of the main licensed laboratory or institution which performs the testing.
Commissioner means the Commissioner of Public Health.
Company means a corporation, a partnership, an association, or an organized group of persons, whether incorporated or not.
Complex laboratory test means a test performed in a physician office which requires sophisticated technique, interpretation of multiple signals and/or proven technical skill. This test requires, but is not limited to one or more of the following steps:
(1) highly skilled physical manipulation;
(2) technique dependent steps in the testing, sampling or reading of results;
(3) user programming of the device or devices;
(4) detailed calculation of the results;
(5) dilution of samples with chemically reactive substances;
(6) preparation of reagents.
Each Day of Use means, for purposes of quality control, each eight hour shift or other regular shift acceptable to the Department within a clinical laboratory.
Exempt test means a test performed in a physician office laboratory which is generally noninstrumental in nature, and the results of which are determined by observation of a visual signal.
Health Promotion Screening Program means a laboratory testing service which examines material derived from a human body for the purpose of promoting health awareness and education among the general public by early detection of disease and/or associated risk factors. Health promotion screening tests are not used for the purpose of providing clinical diagnosis or treatment to patients.
Histocompatibility Testing means any laboratory test procedure the purpose of which is to determine compatibility between a potential organ transplant donor and recipient or to test for a disease associated antigen. A donor organ does not include blood or blood components.
Owner means any individual, partnership, group, firm or corporation holding either partial or complete ownership of or title to a laboratory.
Person and Whoever shall include corporations, societies, associations, partnership, an individual or his estate upon his death, and a political subdivision of the Commonwealth; but not an agency of the Commonwealth.
Personal and Direct Supervision means that a qualified general supervisor or supervisory cytotechnologist, where applicable, is on the premises and immediately available to the bench area when laboratory procedures are being performed.
Proficiency Testing Program means a proficiency testing program which has been approved by the Department. A complete list of proficiency testing programs approved by the Department shall be made available to all laboratories on an annual basis.
Radiobioassay means
(1) an examination to identify radionuclides which are taken in by chronic or acute absorption, ingestion, or inhalation; and
(2) following the administration of a radioactive material to a patient, the subsequent analysis of a body fluid, or excreta in order to evaluate body function.
Satellite laboratory means
(1) a physician office laboratory maintained by three or more physicians performing simple or complex testing, which is located off the premises of the primary or parent office of the group practice and is located in a secondary office of the same group practice; or
(2) a laboratory administered through a state sponsored program, which is located off the premises of the parent laboratory.
Simple laboratory test means a test performed in a physician office laboratory which may require a series of steps/reagent additions or instrumentation, and the results of which are generally determined by a visual signal, but which is not a complex laboratory test as defined in 105 CMR 180.010.
Subsequent to Graduation means laboratory training and experience in an approved clinical laboratory acquired after receipt of the degree or completion of the required academic study specified. For purposes of qualifying as a director ( 105 CMR 180.060) , general supervisor ( 105 CMR 180.115) , technical supervisor ( 105 CMR 180.125) , or technologist ( 105 CMR 180.155) , experience as a technologist in an approved clinical laboratory, which was gained prior to acquiring such degree or completing the required academic study, may be substituted on an equivalency basis of 1.5 years of such experience for every one year of post-degree training and experience; and experience as a general supervisor or technical supervisor in an approved clinical laboratory, which was gained prior to acquiring such degree or completing the required academic study, may be substituted on a one-for-one basis.
Substitution of Education for Experience means for a general supervisor ( 105 CMR 180.115) or technologist ( 105 CMR 180.155) that a minimum of 30 semester hours of credit from either an approved school of medical technology, or towards a bachelor's degree in chemical, physical or biological science from an accredited institution is considered equivalent to 2 years of experience. Additional education shall be equated at the rate of 15 semester hours of credit for one year of experience.
105 CMR, § 180.010