Section 5.11. Permit, requirements, application and conditions

(a) No person, organization or establishment may operate a clinical laboratory in this Commonwealth without first obtaining a permit from the Department.

(b) Application for a permit to operate a clinical laboratory shall be made by the director thereof on forms provided by the Department. The application shall be accompanied by a filing fee of $25 payable to the Department; the fee will be retained by the Department.

(c) The application shall include the following information:

(1) The name and address of the owner or his authorized agent and information regarding the owner as may be required.

(2) The name and address of the clinical laboratory director and other technical personnel to be employed.

(3) Name and address of the clinical laboratory for which the permit is requested and a description and plan of the premises to be occupied for the operation of the laboratory.

(4) A list of the major laboratory equipment to be utilized, including the manufacturer’s name and model number, and other pertinent specifications as may be required on the application form.

(5) The tests to be performed in the clinical laboratory.

(6) The internal and external quality control systems to be employed in the clinical laboratory.

(7) Answers to other questions required in the completion of the application form provided by the Department.

(d) A clinical laboratory director may obtain a permit for all or any designated part of one or more of the following categories:

(1) Microbiology, including the subcategories of bacteriology, virology, mycology, parasitology, syphilis serology and nonsyphilis serology.

(2) Hematology, including immunohematology.

(3) Clinical chemistry, including urinalysis.

(4) Tissue pathology, including exfoliative cytology.

(5) Radioisotope technics.

(e) A category, or subcategory (part), may be retained in a clinical laboratory permit as long as there is evidence that the laboratory functions actively in that category or subcategory and performs a reasonable number of tests to maintain its proficiency, as determined by the Department. Addition of a new category or subcategory may require a period of proficiency evaluation not to exceed 6 months before approval is granted.

(f) No clinical laboratory or other establishment may collect or receive specimens from patients in this Commonwealth for testing unless the laboratory possesses a valid permit issued under this chapter or holds an appropriate Federal license if the laboratory is located outside of this Commonwealth.

(g) A licensed clinical laboratory may send specimens or portions of specimens which it receives to a consulting or reference laboratory approved by the Department. However, the sending clinical laboratory may not serve primarily as a receiving or relay station. A collecting, receiving or relay station may not be maintained by a laboratory or agent of a laboratory which does not hold a currently valid permit to operate a clinical laboratory in this Commonwealth.

(h) In order for a permit to become and remain valid, an annual registration fee shall be paid in full to the Department on or before November 15, 1983, and August 15 of each year thereafter upon receipt of billing forms from the Department. The amount of the fee shall be $100 for each category for which approval is granted. The maximum fee required for each laboratory will not exceed $500 per annum.

The provisions of this § 5.11 amended through October 21, 1983, effective October 22, 1983, 13 Pa.B. 3218. Immediately preceding text appears at serial pages (43941), (66805), and (66806).

Notation

Cross References

This section cited in 58 Pa. Code § 21.8 (relating to boxers).