Pennsylvania Code (Last Updated: April 5, 2016) |
Title 28. HEALTH AND SAFETY |
PART I. General Health |
Chapter 5. Clinical Laboratories |
Section 5.44. Examination of specimens
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(a) No specimen shall be examined if unsuitable for testing because of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection and examination, when applicable, or other reason sufficient to render the findings of doubtful validity.
(b) No specimen of excised tissue shall be subjected to pathological examination except by a person qualified in the field of anatomic pathology. No specimen of exfoliated tissue or cells shall be examined except under the supervision and review of a person qualified in cytopathology. Ten percent of negative cytology preparations and positive or suspicious preparations shall be reviewed by a person qualified in cytopathology. Technical procedures employed in a laboratory shall be the standard procedures which are generally accepted and approved by the Department. Proof that procedures varying from those commonly employed in laboratory practice are accurate may be required by the Department.