Hawaii Administrative Code

The purpose of this chapter is to protect the health, welfare, and safety of the public by establishing minimum licensure standards for clinical laboratories and clinical laboratory personnel. Notes Haw. Code R. § 11-110.1-1 [Eff JUL 05 2007] (Auth: HRS §§ 321-11, 321-13, 321-14,…

(a) The director of a licensed clinical laboratory shall be responsible for: (1) The technical and scientific operation of the laboratory, including the selection and supervision of test procedures, reporting of results, continuous application of quality control procedures, and a…

(a) Clinical laboratories shall designate a clinical laboratory director who is licensed by the State, and testing personnel who meet the qualifications and responsibilities set by the laboratory. If so qualified, each individual may serve in more than one position. (b) Non-licen…

(a) Every specimen received for testing shall be labeled and numbered, or otherwise appropriately identified, and listed in an accession log in chronological order. (b) Every tissue specimen and non-gynecological cytology specimen shall be examined and reported upon by a patholog…

(a) Each licensed clinical laboratory shall retain a duplicate copy of the original report made for each specimen received for analysis for at least two years. (b) Each licensed clinical laboratory shall have a record indicating the daily accession of specimens. The record shall …

(a) Licensed clinical laboratories shall demonstrate to the department proficiency in the performance of the tests offered by the clinical laboratory through state approved proficiency testing programs. The cost of proficiency testing programs shall be borne by the licensed labor…

(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 sp…

(a) All technical procedures used shall be standard procedures which are generally accepted by authorities in the specialties of laboratory medicine or which are approved by the department. Each technical procedure shall be initially approved, signed, and dated by the laboratory …

(a) All licensed clinical laboratories and laboratories with class I and class II permits shall be maintained and operated in a manner which will not expose employees, patients, or the general public to undue physical, chemical, and biological hazards. (b) Laboratories shall be w…

(a) A clinical laboratory certified under 42 C.F.R. part 493 subpart A may operate collecting depots after first obtaining written approval from the department for the establishment of each depot. (b) A collecting depot shall: (1) Have a current, written manual of methods and pro…

(a) A clinical laboratory's permit or license shall not be the subject of sale, assignment, or transfer, voluntary or involuntary, nor shall the license be valid for any location other than that for which it was issued. (b) No establishment other than a clinical laboratory certif…

As used in this chapter: "Accredited college or university" means a regionally accredited college or university in the United States. This definition includes any foreign institution of higher education that the department determines meets substantially equivalent requirements. "…

(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 specif…

Notes Haw. Code R. §§ 11-110.1-21 to 22

(a) No person shall serve as a clinical laboratory director, medical technologist (clinical laboratory scientist), clinical laboratory specialist, cytotechnologist, or medical laboratory technician without a current and valid clinical laboratory-personnel license issued by the de…

Notes Haw. Code R. § 11-110.1-24

A license to practice as a clinical laboratory director may be issued to an applicant who meets one of the following requirements: (1) Is a physician licensed to practice medicine under HRS chapter 4 53 or osteopathy under HRS chapter 460 and is: (A) Certified in anatomical or cl…

A license to practice as a medical technologist (clinical laboratory scientist) may be issued to an applicant who is certified as a medical technologist (clinical laboratory scientist) by a certifying agency acceptable to the department, and who meets one of the following require…

A license to practice as a clinical laboratory specialist in one of the laboratory specialties may be issued to an applicant who is certified by a certifying agency acceptable to the department, in the laboratory specialty for which licensure is sought and who meets one of the fo…

A license to practice as a cytotechnologist may be issued to an applicant who is certified in cytotechnology by a certifying agency acceptable to the department, and who has met one of the following requirements: (1) Holds a bachelor's degree in cytotechnology from an accredited …

Notes Haw. Code R. §§ 11-110.1-29 to 30

The department, upon application, may grant variances and waivers to specific requirements of these rules when the department determines that the intended protections afforded by the rule are being met; and (1) The rule would impede experimentation or demonstration of new and inn…

A license to practice as a medical laboratory technician may be issued to an applicant who is certified as a medical laboratory technician or a medical technologist by a certifying agency acceptable to the department, and who has met one of the following qualifications: (1) Holds…

Notes Haw. Code R. § 11-110.1-32

Any new clinical laboratory personnel licensing requirement that is added by this subchapter shall not be a bar to the license renewal of any person who held a clinical laboratory personnel license immediately prior to the effective date of this subchapter. Notes Haw. Code R. § 1…

(a) A clinical laboratory personnel license may be revoked, suspended, limited, or denied for one or more of the following reasons: (1) A false statement or material omission made on an application for licensure or license renewal or on any other document submitted to the departm…

Notes Haw. Code R. § 11-110.1-35

(a) The department shall not issue an original license or renew a license without first collecting the appropriate fee: (1) Non-refundable application fees for licenses: (A) Clinical laboratory director $25 (B) Medical technologist $25 (C) Clinical laboratory specialist $25 (D) C…

Anyone who violates any provision of this subchapter may be fined not more than $1000 for each day of violation, may be subject to revocation, suspension, restriction, or limitation of licensure or to any other remedies or provisions of §§ 321-15 and 321-20, HRS, and may have rec…

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. § 11-110.1-4 [Eff JUL 05 2007] (Auth: HRS §§ 321-11, 321…

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…