Hawaii Administrative Code

The purpose of this chapter is to specify how the department or its designee shall conduct background checks to ensure the reputable and responsible character of all prospective applicants, operators, direct patient access employees, and adult volunteers of a healthcare facility …

As used in this chapter: "Abuse" means any improper action or activity or any omission of proper action or activity that results in physical, emotional, financial or psychological injury or harm. "Adult day health care" means an organized day program of therapeutic, social, and h…

(a) All applicants and operators shall: (1) Be subject to background checks; and (2) Provide consent to the department or its designee to conduct background checks. (b) All prospective direct patient access employees and adult volunteers of healthcare facilities and, in the case …

(a) The department may revoke or suspend a current license or certificate, impose penalties or fines, deny an application for a license or certificate or a license or certificate renewal, if the applicant, operator, employee, or adult volunteer at the healthcare facility, or, in …

(a) Operators, employees or contractors subject to the requirements of this chapter shall obtain a background check within five working days of operation or hire for the purposes of complying with the requirements of this chapter. (b) Healthcare providers shall make a name inquir…

(a) An applicant, prospective operator, direct patient access employee or adult volunteer, and all adults, other than the clients, living in a healthcare facility operated in a private residence, requesting an exemption from the background check results established by this chapte…

(a) The department shall provide written notice by certified mail of an order to revoke or suspend a current license or certificate, impose penalties or fines, or deny an application for a license or certificate based on this chapter, which shall include the reason for the depart…

Notes Haw. Code R. § 11-11-1 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS §§ 321-1, 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-10 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-11 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-18) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-12 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-9, 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-2 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-3 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11, 321-12) (Imp: HRS §§ 321-11, 321-12) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-4 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-5 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11, 322-42, 445-81, 445-192) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-6 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-7 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS §§ 321-11, 322-1) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-8 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. § 11-11-9 [Eff. DEC 26, 1981] (Auth: HRS §§ 321-10, 321-11) (Imp: HRS § 321-11) R. OCT 27, 2018

Notes Haw. Code R. §§ 11-110-1 to 11-110-36 JUL 05 2007

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