Haw. Code R. § 11-110.1-20 - Violations

(a) If the department determines that any requirements of this subchapter have been violated, the department shall notify the clinical laboratory's laboratory director and owner of the violation in writing by certified mail. In the notice the department shall set forth the specific violations and may do one or more of the following:

(1) Impose fines;

(2) Place restrictions on the permit or license;

(3) Revoke the permit or license;

(4) Establish a specific time for the correction of each correctable violation; and

(5) Approve or disapprove a written plan of correction submitted by the laboratory-director for each correctable violation.

(b) If violations are not corrected within the time specified in the notice or in the accepted plan of correction, the department may do one or more of the following:

(1) Impose fines;

(2) Place restrictions on the permit or license, or

(3) Revoke the permit or license.

(c) The permit or license of a clinical laboratory may be revoked, suspended, or denied for violations of the provisions of this chapter, or for one or more of the following reasons:

(1) A false statement made on an application for a permit or license or any other document submitted to the department;

(2) Knowingly permitting unauthorized persons to perform technical procedures or issue or sign reports;

(3) Consistent errors in performance of laboratory procedures, based on faulty technique or controls;

(4) Dishonest reporting of test results;

(5) Knowingly performing a test and rendering a report thereon to a person not authorized by law to submit the specimens;

(6) Failure to make a report of a communicable disease pursuant to section 11-110.1-16(e); and

(7) Any other activity that is detrimental to the public health.

(d) The director may suspend the permit or license of a clinical laboratory to perform tests in one or more of the specialties or subspecialties stated on a license, for a period not to exceed ninety calendar days, pending the final determination of charges against the laboratory, whenever there has been error in the laboratory tests to such a degree that in the opinion of the director it poses an imminent and substantial danger to the health or life of a patient or member of the public.

(e) A decision to revoke, suspend, restrict, or deny a permit or license shall become final twenty days after the decision was mailed to the laboratory director and owner by certified mail, unless the alleged violator submits a written request for a hearing before the director pursuant to chapter 91, Hawaii Revised Statutes. Upon receipt of the request, the director shall notify the alleged violator of the specific time and location of the hearing.

(f) All written plans of correction shall be submitted to the department within ten calendar days of the department's notification to the laboratory owner or laboratory director of the violation or violations.

Notes

Haw. Code R. § 11-110.1-20

[Eff JUL 05 2007] (Auth: HRS §§ 321-11, 321-13, 321-20) (Imp: HRS §§ 321-11, 321-13)