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The Pennsylvania Code website reflects the Pennsylvania Code changes effective through 54 Pa.B. 2336 (April 27, 2024).

55 Pa. Code § 1243.2. Definitions.

§ 1243.2. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   CLIA—The Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C.A. §  263a).

   Laboratory—A facility for the biological, microbiological, serological, chemical, immunohema-tological, hematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens, or both, or only serving as a mailing service and not performing testing are not considered laboratories.

   Panel test—A series of diagnostically related laboratory tests ordered by a practitioner to confirm a presumptive diagnosis.


   The provisions of this section are amended under sections 201(2), 403 and 443.3 of the Public Welfare Code (62 P. S. § §  201(2), 403 and 443.3).


   The provisions of this §  1243.2 adopted December 5, 1980, effective December 1, 1980, 10 Pa.B. 4614; amended September 5, 2008, effective September 6, 2008, 38 Pa.B. 4898. Immediately preceding text appears at serial page (313036).

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