Hawaii Administrative Code

Subchapter 2 applies to all clinical laboratories within the State, except laboratories that are: (1) Operated by the United States government; (2) Operated and maintained exclusively for research and teaching purposes, involving no patient services whatsoever; (3) Certified by C…

(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 …

(a) A person intending to operate a clinical laboratory may apply for a class I permit if the laboratory: (1) Performs only waived or provider performed microscopy procedures, or both, pursuant to 42 C.F.R. part 493 subpart A, on its premises; (2) Is certified as a clinical labor…

(a) A person intending to operate a clinical laboratory may apply for a class II permit if the laboratory: (1) Is not located in a licensed clinical laboratory; (2) Is maintained by a licensed medical facility for performing tests solely on the facility's patients; (3) Performs o…

(a) A person intending to operate a clinical laboratory may apply for a clinical laboratory license if the laboratory: (1) Is certified as a clinical laboratory under 42 C.F.R. part 493 ; (2) Performs moderate or high complexity tests or both, in addition to any combination of wa…

(a) Any laboratory which is certified by the Substance Abuse and Mental Health Service Administration (SAMHSA) may apply to the department for approval to perform substance abuse tests on samples from the state of Hawaii. (b) A laboratory seeking approval shall submit to the depa…

(a) The director may immediately suspend a laboratory's license if: (1) There is reason to believe that immediate action is necessary to protect the confidentiality of information concerning the tested individual; or (2) There is reason to conclude that factors which significantl…

(a) When the director suspends or seeks to revoke a license, the director shall immediately serve the laboratory with written notice of the suspension or proposed revocation by personal service, or by registered or certified mail, return receipt requested. (b) The written notice …

A suspension shall be effective immediately. A proposed revocation shall be effective thirty days after written notice is given, or, if review is requested, upon the hearing officer's decision to uphold the proposed revocation. If the hearing officer does not uphold the suspensio…

Following the termination or expiration of any suspension or revocation, a laboratory may apply for relicensing. Upon the submission of evidence satisfactory to the director that the laboratory is in compliance with this chapter, and any other conditions imposed as part of the su…

Laboratories seeking license renewal should request renewal in writing to the department not less than three months prior to the expiration date of the license in force. Notes Haw. Code R. § 11-113-14 [Eff 1/23/92; am and Comp OCT 19 2007] (Auth: HRS §§ 329B-4, 329B-8) (Imp: HRS …

(a) The laboratory shall have a scientific director to assume overall professional responsibility for the laboratory's drug testing facility. This individual shall have the following minimum qualifications: (1) A Ph.D. in one of the natural sciences such as toxicology, pharmacolo…

(a) The performance testing program is part of: (1) The initial evaluation of a laboratory seeking a license; and (2) The continuing assessment of laboratory performance necessary to maintain a license. (b) Successful participation in three consecutive cycles of testing shall be …

(a) Initial application for license: (1) An applicant laboratory shall not report any-false positive results during performance testing for initial certification. (2) An applicant laboratory shall maintain an overall grade level of eighty per cent for the three cycles of performa…

(a) When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible tampering and compare information on specimen bottles within each package to the information on the accompanying chain of custody forms. Any direct evidence of t…

(a) Laboratories shall have a quality assurance program which encompasses all aspects of the testing process including but not limited to specimen acquisition, chain of custody, security and reporting of results, initial and confirmatory testing, and validation of analytical proc…

As used in this chapter: "Alcohol" means ethyl alcohol. "Chain of custody" means procedures to account for the integrity of each specimen by tracking its handling and storage from point of specimen collection to final disposition of the specimen. "Collection site" means a place w…

(a) For purposes of this chapter, a medical review officer must possess a current and valid medical review officer license from the director. (b) All requests for a license shall be in writing to the director. (c) To qualify for the license, a person must present evidence of bein…

(a) Any medical review officer license may be revoked or suspended by the director at any time, or may be denied, for any one or more of the following acts or conditions on the part of the holder of such license or the applicant therefor: (1) Being habituated to the excessive use…

(a) When the director seeks to suspend or revoke the license of a medical, review officer, the director shall immediately serve the medical review officer with written notice of the suspension or proposed revocation by personal service, or by registered or certified mail, return …

Following the termination or expiration of any suspension or revocation, the individual may apply for relicensing. Upon the submission of evidence satisfactory to the director that the individual is in compliance with this chapter, and any other conditions imposed as part of the …

A medical review officer seeking license renewal should submit a written request for renewal to the department not less than two months prior to the effective expiration date of the current license. Notes Haw. Code R. § 11-113-24 [Eff 1/23/92; am and Comp OCT 19 2007] (Auth: HRS …

(a) The medical review officer shall receive from the laboratory all positive test results and all chain of custody forms, and from the collection site, information about specimen-individual identifiers. If so desired by the third party, the medical review officer may also receiv…

Specimens shall be placed in containers designed to minimize the possibility of damage during shipment to the substance abuse testing laboratory. The containers shall be securely sealed to eliminate the possibility of undetected tampering. On the tape sealing the container, the s…

Procedures shall be instituted to account for the integrity of each specimen by tracking its handling and storage from the point of specimen collection to final disposition of the specimen. These procedures shall require that a chain of custody form be used from the time of colle…

Notes Haw. Code R. § 11-113-28 [Eff OCT 19 2007]

(a) The report from the laboratory to the medical review officer shall contain information on tests performed on specimens for drugs or the metabolites of drugs, including: (1) The type of test conducted for each specimen. (2) The cutoff level used to distinguish positive and neg…

The conditions of exemption from the provisions of this chapter are the following: (1) Toxicology tests used in the direct clinical management of patients; (2) Tests for alcohol under chapter 286 or 291, Hawaii Revised Statutes; (3) Tests made pursuant to subpart C of the mandato…

The laboratory may transmit test results to the medical review officer by various electronic means in a manner designed to ensure confidentiality of the information. Results may not be provided verbally by telephone. The laboratory shall ensure the security of the data transmissi…

(a) The following fees shall be paid to the department for a laboratory-license: Type of License Screening Confirmatory Both Application $100.00 $100.00 $100.00 Initial license 250.00 500.00 750.00 Renewal of license 100.00 100.00 100.00 Restoration of license 150.00 150.00 150.0…

(a) Any information concerning a substance abuse test pursuant to this chapter shall be strictly confidential. Such information shall not be released to anyone without the informed written consent of the individual tested and shall not be released or made public upon subpoena or …

(a) Any person, agency, or entity that wilfully and knowingly violates any provision of this chapter shall be fined not less than $1,000 but not more than $10,000 for each violation as set by the department, plus reasonable court costs and attorney's fees as determined by the cou…

Should any section, paragraph, sentence, clause, phrase or application of this chapter be declared unconstitutional or invalid for any reason, the remainder of this chapter shall not be affected thereby. Notes Haw. Code R. § 11-113-34 [Eff 1/23/92; am and Comp OCT 19 2007] (Auth:…

Pursuant to this chapter, substances of abuse or their metabolites shall include: (1) Marijuana; (2) Cocaine; (3) Amphetamines; (4) Opiates; (5) Phencyclidine; (6) Barbiturates; (7) Methaqualone; (8) Benzodiazepines; (9) Propoxyphene; (10) Methadone; (11) Alcohol; and (12) Any ot…

(a) Prior to the collection of any sample for substance abuse testing, the individual to be tested shall be supplied by the third party with: (1) A written statement of the specific substances to be tested for; and (2) A statement that over-the-counter medications or prescribed d…

(a) In addition to section 11-113-5, the collection of urine specimens shall include the following: (1) Procedures for collecting urine specimens shall allow for individual privacy unless there is reason to believe that a particular individual may alter or substitute the specimen…

In addition to section § 11-113-5, the collection of blood specimens shall include the following: (1) Blood specimens may be drawn only by a physician, registered nurse, a person with a clinical laboratory personnel license, or a phlebotomist deemed qualified by the director of a…

(a) Laboratories in this State performing substance abuse testing shall be licensed by the department for that purpose. (b) A laboratory seeking a license shall submit to the department a request in writing for an application form. (c) Each license issued pursuant to this chapter…

(a) The director shall revoke the license of any laboratory issued under this chapter if the director determines that the reliability and accuracy of substance abuse tests and the accurate reporting and confidentiality of test results by the laboratory can no longer be ensured. (…

(a) The purpose of this chapter is to ensure that appropriate and uniform forensic alcohol testing is performed throughout the State of Hawaii so that legal criteria are met and reliable and accurate results are assured. (b) This chapter applies to individuals or laboratories who…

(a) Operators of breath alcohol testing instruments shall be responsible for performing breath alcohol tests pursuant to section 11-114-6 and record keeping pursuant to section 11-114-12(b) (1). (b) No person shall serve as an operator unless the person has a valid supervisor's l…

Results of breath alcohol tests when required shall be submitted to the appropriate governmental agency or agencies. Notes Haw. Code R. § 11-114-11 [Eff DEC 30 1993] (Auth: HRS § 321-161) (Imp: HRS §§ 321-161; 286-2; 286-151; 286-152; 286-153; 286-154; 286-155.5; 286-158; 286-160…

(a) Records shall be kept and maintained at the direction of a supervisor. (b) Records shall include information on: (1) Each breath alcohol test conducted; (2) Accuracy tests; and (3) Maintenance and repair of instruments used in the testing of breath for alcohol. (c) Records ma…

(a) The DUI coordinator may conduct on-site surveys of breath alcohol testing locations. (b) Written reports of surveys shall be sent by the DUI coordinator to the chief of police. (c) At no cost to the department, law enforcement jurisdictions in the State shall accept and test …

(a) The DUI coordinator or chief of police may issue supervisor licenses or renewals. (b) The chief of police may issue operator licenses or renewals. (c) The chief of police should submit to the DUI coordinator in June of each year a roster of supervisors and operators, instrume…

(a) A written notice of license revocation shall be issued by the DUI coordinator or the chief of police, whichever issued the license, to any supervisor or operator who: (1) Obtains the license by deception; (2) Falsifies breath alcohol test data or records; or (3) Is no longer …

Notes Haw. Code R. § 11-114-16