GENERAL PROVISIONS
§ 5.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Act—The Clinical Laboratory Act (35 P. S. § § 2151—2165).
Advisory committee—A group of persons as designated by the act who are experienced in the clinical laboratory field and appointed by the Secretary for the purpose of advising the Secretary in matters relating to the administration of the act. At least one member shall be qualified in the discipline of anatomic pathology and one in clinical pathology and licensed to practice medicine in this Commonwealth or eligible for licensure, one shall be qualified in the field of clinical chemistry, and one shall be qualified in the field of clinical microbiology.
Clinical Laboratories Improvement Act of 1967 (CLIA)—Section 353 of the act of July 1, 1944, Pub. L. No. 90-174 (42 U.S.C.A. § 263), and the regulations which apply thereto.
Clinical laboratory—Clinical laboratory includes the following:(i) A place, establishment or institution organized and operated primarily for the performance of bacteriological, biochemical, microscopical, serological or parasitological tests by the practical application of one or more of the fundamental sciences to material originating from the human body, by the use of specialized apparatus, equipment and methods, for the purpose of obtaining scientific data which may be used as an aid to ascertain the state of health. The term includes, but is not limited to, independent, hospital, industrial, state, county and municipal laboratories and clinical laboratories operated in private offices and clinics of practitioners of the healing arts.
(ii) The term does not apply to the office or clinic of a licensed practitioner of the healing arts who performs only the following procedures as part of his or her examinations of the patient to obtain results which are essential for the immediate diagnosis and therapy of the patient:
(A) Chemical examinations of urine by ‘‘Dipstik’’ or tablet methods or both.
(B) Microscopic examination of urine sediment.
(C) Pregnancy tests.
(D) Red and white blood cell counts.
(E) Sedimentation rate of blood.
(F) Gram stain.
(G) Primary culturing for transmittal to a licensed laboratory including pre-incubation, if required.
(H) Qualitative chemical examination of stool specimens.
(I) Test for pinworms.
(J) Test for Trichomonas vaginalis.
(iii) The list set forth in subparagraph (ii) may be revised by the Department in the event it is deemed advisable to add or eliminate specific procedures which either qualify or which no longer qualify as exempt items under the meaning and intent of this section.
(iv) Such procedures may be performed by the practitioners personally or with the aid of an assistant who need not be otherwise qualified.
(v) In the circumstances described in subparagraph (ii), the practitioner shall not be required to obtain a permit before carrying out such laboratory work.
Department—The Department of Health of the Commonwealth.
Director—The person designated by the registrant to be responsible for the daily technical and scientific operations of the laboratory including choice and application of methods, supervision of personnel and reporting of findings.
Owner—Any individual, partnership, group, firm or corporation holding or claiming ownership of or title to a laboratory.
Permit—A license issued by the Department which allows the operation of a clinical laboratory under the provisions of the act.
Secretary—The Secretary of Health of the Commonwealth.
Specimen—Only materials derived from the human body regardless of the physical character of such material.
Supervisor—A properly qualified individual, who, under the direction of an authorized director, may supervise the general activities of a clinical laboratory, or a properly qualified individual who under the direction of an authorized director, may supervise the technical work in a laboratory category.
Technologist—A properly qualified individual according to the provisions set forth in § 5.24 (relating to qualifications of technical personnel).
Source The provisions of this § 5.1 amended through February 26, 1976, 6 Pa.B. 392. Immediately preceding text appears at serial pages (23192) and (23193).
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