Haw. Code R. § 11-110.1-15 - Limitations

(a) A clinical laboratory shall perform only those tests within the limits of its permit or license.

(b) A licensed clinical laboratory shall perform only those tests within the specialties or subspecialties which are stated on its license. The license shall include only those specialties or subspecialties which the clinical laboratory director or testing personnel are qualified to perform. The clinical laboratory director shall notify and seek approval from the department in writing of any changes of specialties or subspecialties at least thirty days prior to the occurrence of each change.

(c) No clinical laboratory license may include the specialty of anatomic pathology or cytology unless tissue specimens or specimens for cytologic examinations are to be examined on the premises by a pathologist or a physician who has demonstrated to the satisfaction of the department that he or she is qualified by education, training, and experience to perform such procedures pursuant to 42 C.F.R. part 493.

Notes

Haw. Code R. § 11-110.1-15

[Eff JUL 05 2007] (Auth: HRS § 321-11) (Imp: HRS § 321-11)