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1 such application for a new license when an existing license 2 is to become or has become void, as a result of this section, 3 shall be granted priority consideration by the Surgeon Gen4 eral. in order to permit the uninterrupted operation of the 5 laboratory. A change in the ownership of any clinical lab6 oratory shall not be considered to have occurred for purposes 7 of this subsection whenever there is a sale, transfer, or 8 other disposition of an interest in the ownership of such lab

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oratory made under conditions which do not change in 10 substance the management and operation of the professional

11 aspects of such laboratory. The Surgeon General shall define

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by regulations the types of sales, transfers, or other disposi13 tions that will not be considered changes in ownership for 14 purposes of this subsection.

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SEC. 6. (a) In order to administer effectively the pro16 visions of this Act, the Surgeon General, or his designee, may 17 at all reasonable times inspect the facilities, methods, proce18 dures, materials, staff, and equipment of any clinical labora19 tory subject to the provisions of this Act.

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(b) The Surgeon General may require clinical labora21 tories subject to the provisions of this Act to submit periodic

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reports of procedures performed in such laboratories and such 23 other information as the Surgeon General determines neces

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sary or appropriate to facilitate the administration of this

25 Act. The Surgeon General may require such laboratories to

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1 submit lists showing the names of all personnel employed to 2 perform laboratory procedures, the technical qualifications of 3 such personnel, and to notify the Surgeon General promptly 4 of any changes in such personnel.

5 (c) The Surgeon General shall prescribe standards of 6 performance for the examination of specimens submitted to 7 any clinical laboratory subject to the provisions of this Act. 8 In carrying out the provisions of this Act, the Surgeon Gen9 eral may require any such laboratory to analyze test samples 10 submitted by him and to report to him on the results of such 11 analyses. Such analyses and reports may be considered by 12 the Surgeon General in making any finding under section 8 13 of this Act.

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(d) The Surgeon General may appoint one or more 15 advisory committees of persons expert in the major categories 16 of laboratory procedures to advise him in connection with the 17 qualifications of technical personnel employed in clinical 18 laboratories, the appropriateness of laboratory procedures, 19 and the performance of his responsibilities under this Act. 20 SEC. 7. (a) No person shall act as the laboratory di21 rector of any clinical laboratory subject to the provisions of 22 this Act unless a certificate of qualification has been issued to him as provided in this section. A certificate of quali24 fication shall be issued authorizing the holder to direct one

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or more laboratory procedures or one or more categories of 2 such procedures.

3 (b) The Surgeon General shall prescribe minimum 4 qualifications for laboratory directors in microbiology, serol5 ogy, chemistry, hematology, biophysics, cytology, or 6 pathology.

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(c) A certificate of qualification shall be issued to any 8 person who meets the minimum qualifications prescribed 9 by the Surgeon General and who otherwise demonstrates 10 that he possesses the character, training, and ability to 11 administer properly the technical and scientific operation of a clinical laboratory, including supervision of procedures and 13 reporting of findings of tests.

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14 (d) Application for a certificate of qualification shall 15 specify the procedures or categories of procedures for which 16 the certificate is sought and such other information as the 17 Surgeon General may require.

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(e) A certificate of qualification issued under this Act 19 shall be valid for a period of five years from the date of 20 its issuance and may be renewed for successive five-year 21 periods thereafter, if the applicant continues to meet the 22 qualifications specified by the Surgeon General. The Sur23 geon General may impose a fee for the issuance of a cer24 tificate of qualification and for each renewal thereof but 25 such fee shall not exceed $25.

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(f) The Surgeon General may issue a temporary cer2 tificate of qualification to any person pending the issuance 3 of a regular certificate under this section, but a temporary 4 certificate shall be valid for a period of only thirty days 5 and may be renewed for not to exceed four successive 6 periods of thirty days.

7 SEC. 8. (a) A laboratory license or certificate of qualifi8 cation may be revoked, suspended, or limited if the Surgeon 9 General finds, after notice and hearing, that the owner of 10 the laboratory, the holder of the certificate of qualification, 11 or any employee of the laboratory—

(1) has been guilty of misrepresentation in obtaining the license or certificate or in the operation of the laboratory;

(2) has knowingly accepted or permitted to be accepted a specimen or assignment for laboratory examination from, or rendered a report thereon to, a

person or persons not authorized under the law of the

State from which the specimen was sent to submit

such assignment or specimen or receive such report;

(3) has engaged or attempted to engage or represented himself as entitled to perform any laboratory

procedure or category of procedures not authorized in

the license or certificate;

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121

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(4) has failed to comply with the standards prescribed by the Surgeon General under section 6 (c) of this Act for the examination of specimens;

(5) has rendered a report on laboratory work actually performed in another laboratory without designating the fact that the examination or procedure was performed in another laboratory;

(6) has demonstrated incompetence or has shown consistent errors in the performance of laboratory examinations or procedures;

(7) has failed to file any report required by the provisions of this Act or by any rule or regulation pro

mulgated thereunder; or

(8) has violated or aided and abetted in the violation of any provisions of this Act or of any rule or reg ulation promulgated thereunder.

(b) No laboratory license or certificate of qualification 18 shall be revoked, suspended, or limited until after notice and

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hearing in accordance with subchapter II of chapter 5 of 20 title 5, United States Code, relating to administrative proce21 dure, has been provided, except that a laboratory license or a certificate of qualification may be temporarily suspended

22.

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without a hearing for a period of not to exceed thirty days 24 if the Surgeon General determines that the public safety or 25 welfare is in imminent danger.