Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.010 - Definitions

Current through Register 1525, July 5, 2024
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.
				405.1310
et 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				where materials orspecimens are either withdrawn or collected from patients or
				assembled after being withdrawn of collected elsewhere from patients for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.