Haw. Code R. § 11-110.1-6 - Requirements for a clinical laboratory permit or license

(a) No person shall establish, conduct, maintain, or operate a clinical laboratory in the State without a valid and effective clinical laboratory permit or license issued by the department.

(b) An application shall be submitted for each address in which clinical laboratory tests are performed.

(c) The following laboratories shall be exempt from the requirements of subsection (b):

(1) Clinical laboratories located within contiguous buildings in a hospital, share the same address, and under the direction of the same laboratory director may apply for a single license or permit.

(2) Laboratories that are not at a fixed location, that is, laboratories that move from testing site to testing site, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations may be covered under the license or permit of the designated primary site or home base, using the address of the primary site or home base.

(3) Not-for-profit or State or local government laboratories that engage in limited (not more than a combination of fifteen PPMPs, POCTs or waived tests per license or permit) public health testing may file a single application.

(d) All completed applications shall be approved or denied no later than sixty calendar days following the date that the complete application is received.

(e) A clinical laboratory license or permit shall be effective for a period of not more than twenty-four months.

(f) The clinical laboratory director shall display the permit or license issued to the laboratory by the department in a prominent place in the laboratory.

(g) The clinical laboratory director shall notify the department in writing of a change in name, location, director, or owner of the laboratory within thirty days of the actual change.

Notes

Haw. Code R. § 11-110.1-6

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