Alabama Administrative Code › Title 420 - ALABAMA STATE BOARD OF HEALTH › Chapter 420-5-8 - INDEPENDENT CLINICAL LABORATORIES › Section 420-5-8-.01 - General

Current through Register Vol. 42, No. 9, June 28, 2024
(1) Legal Authority
			 for Adoption of Rules. Under and by virtue of authority vested in it by the
			 Legislature of Alabama,
Code of Ala. 1975
, Section
			 22-21-20,
et
seq
., requiring
			 independent clinical laboratories and health care institutions engaged in
			 offering diagnostic services to be licensed by the Alabama State Board of
			 Health, the State Board of Health does hereby adopt and promulgate the
			 following Rules governing all independent clinical laboratories and all
			 independent physiological laboratories and other related institutions in
			 Alabama, except those operated under the supervision of the Department of
			 Mental Health and those laboratories otherwise exempt by law from licensure.
			 Sections 420-5-8.01, 420-5-8.02, 420-5-8.05, and 420-5-8.06 are applicable to
			 independent physiological laboratories. All sections of these Rules, except
			 section 420-5-8.05 are applicable to independent clinical
			 laboratories.
(2) Definitions. (A
			 list of selected terms often used in connection with these Rules):
(a) "AAC Rule" means Alabama Administrative
			 Code Rule.
(b) "Accredited" means
			 accreditation by a nationally recognized accrediting agency or association as
			 determined by the U.S. Commissioner of Education or the Alabama Department of
			 Public Health.
(c) "Advisory
			 Board." See Section
			 22-21-27 of the Appendix to these
			 Rules.
(d) "Biophysical Procedures"
			 means procedures wherein specimens which have been removed from the human body
			 are subjected to biophysical determinations.
(e) "Board" or "State Board of Health" means
			 the Alabama State Board of Health.
(f) "Collection Station" means a facility
			 where materials or specimens are withdrawn or collected from patients for
			 subsequent delivery to a clinical laboratory for examination. Physicians'
			 offices are exempted from this definition.
(g) "Director" means any qualified person
			 responsible for administration of technical and scientific operations of a
			 laboratory, including supervision of testing procedures and result
			 reporting.
(h) "Independent
			 Clinical Laboratory" means any laboratory which operates primarily independent
			 of other health care facilities that are licensed by the Alabama State Board of
			 Health, or hospital laboratories that receive and perform reference work from
			 sources outside of the hospital, and performs diagnostic and medical laboratory
			 procedures upon referral. Independent clinical laboratory shall include
			 laboratories operated by blood banks, plasmapheresis banks, radioisotope
			 facilities, specimen collection stations, and laboratories engaged in
			 manufacturing diagnostic test reagents from human whole blood or whole blood
			 derivatives. Federal and State laboratories shall be excluded from these
			 Rules.
(i) "Independent
			 Physiological Laboratory" means any facility or unit, mobile or otherwise, that
			 provides diagnostic physiological services for humans, for example, pulmonary
			 function tests, spirometer, EKG, Holter monitor, EEG, transtelephonic pacemaker
			 analysis, oximetry, diagnostic hearing tests, echo-ultrasound, diagnostic ultra
			 sound, doppler studies, and non-invasive peripheral vascular studies.
			 Facilities that provide ionizing radiation or magnetic resonance imaging only
			 are excluded from this definition. Private physician offices performing
			 diagnostic physiological services exclusively for their patients are excluded
			 from this definition.
(j) "License"
			 means the document issued by the State Board of Health and signed by the State
			 Health Officer. The license shall constitute the authority to receive patients
			 and perform the services included within the scope of these Rules.
(k) "Licensee" means the corporate body or
			 individual to whom the license is issued and upon whom rests the responsibility
			 for compliance with these Rules.
(l) "Licensed Practitioner of the Healing
			 Arts" means a person currently licensed to practice medicine and surgery in the
			 State of Alabama.
(m) "May"
			 indicates permission.
(n) "Mobile
			 Unit" means a laboratory testing unit, either independent clinical or
			 independent physiological, that moves from testing site to testing site, or has
			 a temporary testing location. The mobile unit shall provide the State Board of
			 Health with an Alabama permanent address and an address of the physical
			 location of the home base. The mobile unit must submit to the Board a monthly
			 schedule of hours of operation and of the locations the mobile unit will be
			 performing the procedures.
(o)
			 "Patient" means a person referred to the independent clinical laboratory by and
			 upon the recommendation of a physician.
(p) "Physician" means a person currently
			 licensed to practice medicine in Alabama under the provisions contained in
			 current state statutes.
(q)
			 "Plasmapheresis and Whole Blood Centers" mean facilities which provide a system
			 for collection, processing or storage of human blood and/or its components.
			 Plasmapheresis and whole blood donor centers operating within this state shall
			 obtain a license from the Alabama Department of Public Health. Such
			 plasmapheresis and whole blood donor centers shall be maintained in accordance
			 with the AAC Rule 420-5-8.02, 420-5-8.03(1)(a)(1), 420-5-8.04(1)(a),
			 420-5-8.04(4), 420-5-8.04(5)(c), and 420-5-8.06.
(r) "Qualifying Adjectives," such as
			 adequate, proper, safe, sufficient, satisfactory, suitable, and substantial
			 mean the degree of propriety or compliance that is being maintained by other
			 independent clinical laboratories in Alabama that currently hold a regular
			 license issued by the State Board of Health.
(s) "Shall" indicates mandatory
			 requirements.
(t) "Supervisor"
			 means any qualified person who, under general supervision of a director,
			 supervises technical personnel, performs tests requiring special scientific
			 skills, and in the absence of the director, is held responsible for proper
			 performance of all laboratory procedures and the reporting of
			 results.
(u) "Technician" means any
			 qualified person who functions under the direct supervision of a director,
			 supervisor, or technologist and performs only those clinical laboratory
			 procedures which require limited skill, responsibility, and a minimal exercise
			 of independent judgment.
(v)
			 "Technologist" means any qualified person who performs tests which require the
			 exercise of independent judgment and responsibility with supervision by the
			 director or supervisor, in only those specialties or subspecialties in which
			 the person is qualified by education, training, and experience.
(w) "These Rules" means Rules 420-5-8.01
			 through 420-5-8.06, Chapter 420-5-8, Independent Clinical Laboratories, Alabama
			 Administrative Code.
(x) "Trainee"
			 means any person who is employed to perform services with or without
			 remuneration or for the direct or indirect benefit of a clinical laboratory or
			 owner and is being trained for the category for which he has applied.