§ 5.41. Acceptance and collection of specimens.
(a) Specimens shall be accepted or collected from patients by a clinical laboratory only when tests are requested on the specimens by a member of the healing arts licensed to practice in this Commonwealth, or other persons authorized by statute, or authorized agents of the foregoing.
(b) No specimen shall be collected by an owner, an employe or other person associated with the clinical laboratory except under one of the following conditions:
(1) The person is a member of the healing arts licensed in this Commonwealth or a laboratory director qualified under the Clinical Laboratory Act of 1951 (P. L. 1539) (35 P. S. § 2151 et seq.).
(2) The person is collecting the specimen under the direction of a member of the healing arts licensed in this Commonwealth or a laboratory director qualified under the Clinical Laboratory Act.
(c) This section does not prohibit the transmission of specimens collected as set forth in subsection (b) under the following circumstances:
(1) To another laboratory licensed under the Clincial Laboratory Act.
(2) To a Federal laboratory.
(3) To a laboratory located in another state providing that laboratory has been issued a license or permit in conformity with the Clinical Laboratories Improvement Act of 1967 (35 P. S. § 2151) and related regulations.
(d) The acceptance of specimens submitted by a representative of the Department, or designated agent, for purposes of evaluation of testing procedures is not prohibited.
Notes of Decisions
A blood test performed by a trained phlebotomist under standard hospital procedures under directors of a physician and met the requirements of this section. Commonwealth v. Dungan, 539 A.2d 817 (Pa. Super. 1988); appeal denied 559 A.2d 34 (Pa. 1989).
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