2009 New Jersey Code
TITLE 45 - PROFESSIONS AND OCCUPATIONS
Section 45:9
45:9-42.34 - Rules and regulations;  operation of clinical laboratories; standards

45:9-42.34.  Rules and regulations;  operation of clinical laboratories; standards
    The Public Health Council of the department shall promulgate rules and regulations for operation of clinical laboratories which shall be incorporated in and made a part of the State Sanitary Code.  Where feasible such rules and regulations shall equal or exceed minimum standards for laboratory certification contained in Federal rules and regulations promulgated pursuant to the  "Clinical Laboratories Improvement Act of 1967"  (Public Law 90-174) 42  U.S.C. 263a.  The rules and regulations so promulgated shall include but shall  not be limited to standards for:

    a.  Construction of new, or modification of existing clinical laboratories.

     b.  Sanitary and safe conditions within the clinical laboratory and its surroundings, including adequate working space, lighting, fire prevention and safety measures.

    c.  Clinical laboratory equipment, maintenance procedures for such equipment  and personnel essential to proper conduct and operation of a clinical  laboratory, including standards for education, experience, continuing  education, and periodic proficiency testing for laboratory directors,  supervisors, technicians, and other personnel which the department may deem  necessary for adequate laboratory staffing.

    d.  The acceptance, collection, transportation, identification and examination of clinical laboratory specimens and reporting of results by clinical laboratories.

    e.  Reporting by laboratories of diseases for the protection of the public health.  The department shall furnish forms for this purpose.  Such reports shall not be construed as constituting a diagnosis nor shall any clinical laboratory making such report be held liable under the laws of this State for having violated a trust or confidential relationship.

    f.  Submitting such reports concerning clinical laboratory operations as may  be necessary to administer this act.  Each laboratory shall maintain a manual  of procedures followed in that laboratory, which shall be reviewed and updated  annually.  Such manual shall also include, but not be limited to, a list of  equipment used for each procedure.

    g.  Exemptions of specific types of clinical laboratories from the provisions of section 7 of P.L.1971, c. 136 (C. 26:2H-7).

     L.1975, c. 166, s. 9, eff. Aug. 1, 1975.