reglab/statecodes huggingface dataset:
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 2 - CLINICAL LABORATORIES › Section 11-110.1-20 - Violations

Current through June, 2024
(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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-23 - Clinical laboratory personnel license

Current through June, 2024
(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 department.
(b) Application forms for licensure may be
				  obtained by request from the state laboratories division, department of
				  health.
(c) The clinical laboratory
				  personnel licenses are:
(1) Clinical
				  laboratory director;
(2) Medical
				  technologist (clinical laboratory scientist);
(3) Clinical laboratory specialist;
(4) Cytotechnologist; and
(5) Medical laboratory technician (clinical
				  laboratory technician).
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-25 - Clinical laboratory director

Current through June, 2024
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 clinical pathology or in one of the clinical laboratory
				  specialties by the American Board of Pathology or the American Osteopathic
				  Board of Pathology; or
(B)
				  Certified by the American Board of Medical Microbiology, the American Board of
				  Clinical Chemistry, the American Board of Bioanalysis, the American Board of
				  Medical Laboratory Immunology, or other certifying agency acceptable to the
				  department, in one of the laboratory specialties;
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-26 - Medical technologist (clinical laboratory scientist)

Current through June, 2024
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
					 requirements:
(1) Holds a bachelor's
				  degree in medical technology from an accredited college or university and has
				  successfully completed an accredited program of medical technology;
(2) Holds a bachelor's degree in medical
				  technology from an accredited college or university and has completed one year
				  of full-time experience as a medical laboratory technician in a clinical
				  laboratory acceptable to the department;
(3) Holds a bachelor's degree in a chemical,
				  physical, or biological science from an accredited college or university which
				  includes completing:
(A) Sixteen semester
				  hours in chemistry courses of which at least six semester hours are in
				  introductory college chemistry that are acceptable toward a major in chemistry;
				  and
(B) Sixteen semester hours in
				  biology courses that are pertinent to the clinical laboratory sciences and are
				  acceptable towards a major in the biological sciences; and
(C) Three semester hours in college
				  mathematics; and has completed one year of full-time clinical laboratory
				  experience that included a minimum of two months each in clinical chemistry,
				  clinical microbiology, hematology, immunology and immunohematology in a
				  laboratory acceptable to the department;
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-27 - Clinical laboratory specialist

Current through June, 2024
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
					 following requirements:
(1) Holds a
				  bachelor's degree in a pertinent chemical, physical, or biological science, as
				  determined by the director, from an accredited college or university and has
				  successfully completed at least one year of pertinent full-time clinical
				  laboratory experience in a laboratory acceptable to the department or one year
				  of training in an accredited program, or both, in the specialty for which
				  licensure is sought; or
(2) Has
				  successfully completed at least ninety-semester hours (or their equivalent)
				  from an accredited college or university and one year of training in a
				  accredited program in the laboratory specialty for which licensure is sought.
(A) An applicant who completed training prior
				  to September 15, 1963 must have twenty-four semester hours in chemistry and
				  biology courses of which:
(i) Six semester
				  hours were in introductory college chemistry and three semester hours were in
				  other chemistry courses; and
(ii)
				  Twelve semester hours were in biology courses pertinent to the clinical
				  laboratory specialty for which licensure is sought;
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-28 - Cytotechnologist

Current through June, 2024
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 college or university;
(2) Holds a bachelor's degree in a chemical,
				  physical, or biological science and has successfully completed an accredited
				  program in cytotechnology;
(3)
				  Before September 1, 1992, has successfully completed at least sixty semester
				  hours (or their equivalent) in an accredited college or university with at
				  least twelve semester hours in science, eight of which are in biology; and:
(A) Completed twelve months of training in an
				  accredited program of cytotechnology; or
(B) Completed six months of formal training
				  in an accredited program of cytotechnology and six months of full-time
				  experience in a clinical laboratory under the direct supervision of a
				  pathologist who is certified in anatomic pathology by the American Board of
				  Pathology or the American Osteopathic Board of Pathology;
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-31 - Medical laboratory technician (clinical laboratory technician)

Current through June, 2024
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 an associate degree from an
				  accredited program for medical laboratory technicians;
(2) Has successfully completed at least sixty
				  semester hours (or their equivalent) which included courses in chemistry and
				  biology from an accredited college or university and has either of the
				  following:
(A) Completed an accredited
				  program for medical laboratory technicians; or
(B) Completed an advanced military medical
				  laboratory technician course in the United States Armed Forces of at least
				  fifty weeks duration and held the military enlisted occupational specialty of
				  Medical Laboratory Specialist (laboratory technician) within the five years
				  immediately prior to date of application for licensure.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-33 - Exemptions

Current through June, 2024
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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-34 - Revocation, suspension, limitation, or denial of a clinical laboratory personnel license

Current through June, 2024
(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 department;
(2) False reporting or knowingly permitting
				  false reporting of test results;
(3) Conviction, whether by nolo contendere or
				  otherwise, of a felony or any penal offense substantially related to the
				  qualifications, functions, or duties of clinical laboratory personnel under the
				  laws of any state of the United States or of the federal government. The record
				  of conviction or a certified copy thereof shall be conclusive evidence of such
				  conviction;
(4) Allowing
				  unauthorized persons or unqualified persons to perform technical laboratory
				  procedures or to issue or to sign reports;
(5) Excessive number of errors in the results
				  of tests performed, supervised, or directed by the licensee;
(6) Performing a test and rendering a report
				  thereon to a person who is not an authorized person;
(7) Any conduct that poses an immediate and
				  serious threat to patient health and safety, including performing or
				  supervising laboratory tests which the licensee is unqualified to supervise or
				  to perform;
(8) Being habituated to
				  the excessive use of drugs or alcohol; or being addicted to, dependent on, or a
				  habitual user of a narcotic, barbiturate, amphetamine, hallucinogen, or other
				  drug having similar effects;
(9)
				  Practicing in a clinical laboratory while the ability to practice is impaired
				  by alcohol, drugs, or mental instability;
(10) Violation of Child Support Enforcement,
				  chapter
				  576D, HRS; or
(11) Revocation, suspension, or any other
				  disciplinary action by another state of a license or certificate for reasons as
				  provided in this subsection or any disciplinary action of a practice privilege
				  by any agency of the United States.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-36 - Fees

Current through June, 2024
(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) Cytotechnologist
$25
(E) Medical laboratory technician
$25
(2) License fee:
(A) Clinical laboratory director
$50
(B) Medical technologist
$40
(C) Clinical laboratory specialist
$40
(D) Cytotechnologist
$40
(E) Medical laboratory technician
$40
(3) License renewal fee:
(A) Clinical laboratory director
$40
(B) Medical technologist
$30
(C) Clinical laboratory specialist
$30
(D) Cytotechnologist
$30
(E) Medical laboratory technician
$30
(4) Restoration fee:
$20
(b) All fees shall be collected by the
				  department at the time of application for initial licensure, license renewal,
				  and restoration of license.
(c)
				  Requests for license renewal and the renewal fees must be received by the
				  department by January 31 of each odd-numbered year starting in the year 2003.
				  The failure, neglect, or refusal of any person holding such license to request
				  renewal or to pay the renewal fee after thirty days of delinquency shall
				  constitute a forfeiture of the person's license; provided that a forfeited
				  license may be restored upon written application and payment of all delinquent
				  fees. If a license is forfeited for one year and less than two years, the
				  department may request that the applicant submit additional information and
				  evidence satisfactory to the department, including passing of an examination,
				  or showing that the applicant remains fit to practice as a clinical laboratory
				  personnel, or both before the license is restored. A license that has been
				  forfeited for two years or more shall not be restored and a new application for
				  license shall be required.
(d) A
				  fee shall be paid for the restoration of a license suspended pursuant to
				  chapter 436C, HRS, or pursuant to chapter
				  576D, HRS.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 3 - CLINICAL LABORATORY PERSONNEL › Section 11-110.1-37 - Violations

Current through June, 2024
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 recourse to an administrative hearing in accordance with chapter 91, HRS,
					 and the department's rules of practice and procedure.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-1 - Purpose

Current through June, 2024
The purpose of this chapter is to ensure that appropriate
				  and uniform substance abuse test procedures are employed throughout the State,
				  to protect the privacy rights of persons tested, and to achieve reliable and
				  accurate results.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-3 - Exemptions

Current through June, 2024
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 mandatory Guidelines for Federal
				Workplace Drug Testing Programs (53 Federal Register 11986); and
(4) Substance abuse testing of individuals
				under the supervision or custody of the judiciary, the department of public
				safety, the Hawaii paroling authority, and the office of youth
				services.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-4 - Substances of abuse

Current through June, 2024
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 other controlled substances in
				chapter
				329, Hawaii Revised Statutes, and
				approved by the director in writing.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-5 - Specimen collection

Current through June, 2024
(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 drugs may result in a positive test result;
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-7 - Blood specimen

Current through June, 2024
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 clinical
				laboratory which is licensed by the state.
(2) The area of puncture shall be thoroughly
				cleansed and disinfected with an aqueous solution of non-volatile antiseptic.
				Alcohol shall not be used as a disinfectant if the blood specimen shall be
				tested for alcohol content.
(3)
				Blood shall be drawn with a sterile dry needle into a vacuum container; or a
				sterile dry needle and syringe and deposited in a clean dry container. The
				container shall be capped or stoppered and sealed.
(4) Each specimen must have the following
				information:
(A) The individual's specimen
				number.
(B) Date, time and place of
				blood specimen collection.
(C) Name
				of the person drawing blood; and
(D) Type and amount of preservative or
				anticoagulant, or both, used, if any.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-8 - Licensing of laboratories

Current through June, 2024
(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 shall be issued to the owner of the laboratory and shall expire within
				twenty-four months from the date of issuance.
(d) A laboratory must meet all of the
				following provisions to qualify for a license:
(1) The laboratory is located in this
				State.
(2) Laboratory personnel
				meet the qualifications specified in section §
										11-113-15.
(3) The laboratory facility performing
				substance abuse testing shall be secured.
(4) The laboratory shall use proper chain of
				custody procedures.
(5) The
				laboratory shall use screening or confirmatory testing procedures, or both,
				which are acceptable to the director.
(6) The laboratory shall have a quality
				assurance program which is acceptable to the director.
(7) The laboratory must be enrolled in a
				performance testing program which is acceptable to the director, at no cost to
				the department.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-9 - Revocation of laboratory license

Current through June, 2024
(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.
(b) The following factors shall be considered
				in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing
				and reporting the results of drug tests;
(2) Unsatisfactory results in performance
				testing or laboratory inspections;
(3) Unsatisfactory participation in testing
				of specimens provided by the department;
(4) A material violation of any licensure
				provision in this chapter;
(5)
				Conviction for any criminal offense by key personnel of the laboratory in any
				incident directly related to the operations or maintenance of the laboratory,
				pursuant to chapter 831, Hawaii Revised Statutes;
(6) Violation of any procedures which ensure
				confidentiality of substance abuse information; and
(7) Any other cause which materially affects
				the ability of the laboratory to ensure the reliability and accuracy of drug
				tests and the accurate reporting of results, as determined by the
				director.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-10 - Suspension of laboratory license

Current through June, 2024
(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 significantly affect the achievement
				of reliable and accurate test results exist, as determined by the
				director.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-11 - Opportunity for review of revocation and suspension of laboratory license

Current through June, 2024
(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 shall state that the
				laboratory will be afforded an opportunity for a hearing of the suspension or
				proposed revocation if it so requests in writing within thirty days of the date
				of mailing or service of the notice. The review shall be conducted by one or
				more hearing officers designated by the director.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-12 - Suspension effective date

Current through June, 2024
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 suspension or proposed
				  revocation, the suspension shall terminate immediately and any proposed
				  revocation shall not take effect.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-13 - Relicensing of laboratory

Current through June, 2024
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 suspension or
				  revocation, the director may relicense the laboratory.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-14 - Renewal of laboratory license

Current through June, 2024
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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-15 - Laboratory personnel

Current through June, 2024
(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, pharmacology, chemistry, or
				biological chemistry, or training and experience comparable to a Ph.D. in one
				of the natural sciences, such as a medical or scientific degree with additional
				training and laboratory/research experience in toxicology, pharmacology,
				chemistry, or biological chemistry; and
(2) Appropriate experience in analytical
				forensic toxicology.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-16 - Performance test requirement for licensure

Current through June, 2024
(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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-17 - Evaluation of performance testing

Current through June, 2024
(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 performance
				testing required for initial certification, as determined by the performance
				testing program or by the director when applicable.
(3) An applicant laboratory shall obtain at
				least eighty per cent of its quantitative values for confirmatory testing which
				are within plus or minus twenty per cent or plus or minus two standard
				deviations of the reference group mean (whichever is larger). Failure to
				achieve eighty per cent will result in disqualification.
(4) An applicant laboratory shall not obtain
				any quantitative values that differ by more than fifty per cent from the
				calculated reference group mean. Any quantitative values that differ by more
				than fifty per cent will result in disqualification.
(5) For any individual substance of abuse or
				metabolite, an applicant laboratory shall successfully detect and quantitate in
				accordance with paragraphs (2), (3) and (4) at least fifty per cent of the
				total drug challenges. Failure to successfully quantitate at least fifty per
				cent of the challenges for any individual drug will result in
				disqualification.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-18 - Laboratory procedures for urine specimens

Current through June, 2024
(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 tampering or discrepancies in the
				information on specimen bottles and the chain of custody forms attached to the
				shipment shall be immediately reported to the third party and shall be noted on
				the chain of custody form which shall accompany the specimens while they are in
				the laboratory's possession.
(b)
				Specimen bottles or containers will normally be retained within the
				laboratory's accession area until all analyses have been completed. Aliquots
				and the laboratory's chain of custody forms shall be used by laboratory
				personnel for conducting tests.
(c)
				Specimens that do not receive a test within seven days of arrival at the
				laboratory shall be placed in secure refrigeration units at temperatures not
				exceeding ten degrees Centigrade. Emergency power equipment shall be available
				in case of prolonged power failure.
(d) When conducting either screening or
				confirmatory tests, each batch of specimens shall contain an appropriate number
				of standards for calibrating the instrumentation and a minimum of ten per cent
				of controls.
(e) Except for
				additional testing to determine the validity of the specimen, no laboratory
				shall test for any substance which is not included in a written statement from
				the third party specifying the substances to be tested for. Such additional
				tests may include the following:
(1)
				Creatinine and specific gravity: the specimen is considered "diluted" if the
				creatinine concentration is greater than or equal to 2 mg/dl but less than 20
				mg/dl and the specific gravity is greater than 1.001 but less than 1.003. The
				specimen is considered "substituted" (i.e., the specimen does not exhibit the
				clinical signs or characteristics associated with normal human urine) if the
				creatinine concentration, is less than 2 mg/dl and the specific gravity is less
				than or equal to 1.001, or greater than or equal to 1.020.
(2) Nitrite: the specimen is considered
				"adulterated" if nitrite is equal to or greater than 500 mcg/ml.
(3) pH: the specimen is considered
				"adulterated" if the pH is less than 3 or equal to or greater than
				11.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-19 - Quality assurance and quality control

Current through June, 2024
(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 procedures. Quality
				assurance procedures shall be designed, implemented, and reviewed to monitor
				the conduct of each step of the process of testing.
(b) Each analytical run of specimens to be
				screened shall include:
(1) Specimens
				certified to contain no drugs;
(2)
				Specimens fortified with known standards; and
(3) Positive controls with the drug or
				metabolite at or near the cutoff.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-19.1 - Approval of laboratories

Current through June, 2024
(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 department a duly completed application form.
(c) Each approval shall expire within twelve
				months from the date of approval.
(d) Approved laboratories must use SAMHSA
				approved methods for testing samples from Hawaii.
(e) Methods for testing non-SAMHSA analytes
				must be approved by the director.
(f) Laboratory approval will be revoked if
				any one of the provisions of subsections (a) through (e) is not met.
(g) The director shall keep a current listing
				of all approved laboratories which perform substance abuse tests on samples
				from Hawaii. This listing may be sent to any third party upon written
				request.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-20 - Medical review officer license

Current through June, 2024
(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 being a physician
				licensed to practice medicine in this or another state, and of knowledge of
				substance abuse disorders. After review of an applicant's professional
				experience in substance abuse, the director may issue a license to the
				applicant.
(d) The term of the
				license shall not be greater than twenty-four months from the date of
				issue.
(e) Any physician licensed
				pursuant to this section shall possess a current physician's license at all
				times.
(f) The director shall keep
				a current listing of all medical review officers practicing in the State. This
				listing may be sent to any third party upon written request.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-21 - Revocation, suspension, or denial of medical review officer license

Current through June, 2024
(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 of drugs or alcohol; or being addicted to,
				dependent on, or an habitual user of a narcotic, barbiturate, amphetamine,
				hallucinogen, or other drug having similar effects;
(2) Practicing as a medical review officer
				while the ability to practice is impaired by alcohol, drugs, or mental
				instability;
(3) Procuring a
				license through fraud, misrepresentation, or deceit or knowingly permitting an
				unlicensed person to perform activities requiring a license;
(4) Professional misconduct, gross
				negligence, or manifest incapacity in functioning as a medical review
				officer;
(5) Revocation,
				suspension, or other disciplinary action by another state or federal agency of
				a license or certificate for reasons as provided in this section;
(6) Conviction, whether by nolo contendere or
				otherwise, of a penal offense related to the qualifications, functions, or
				duties of a physician;
(7)
				Violation of chapter
				329, Hawaii Revised Statutes, Uniform
				Controlled Substance Act, or any administrative rule adopted
				thereunder;
(8) Failure to report
				to the director, in writing, any disciplinary decision issued against the
				licensee or the applicant in another jurisdiction within thirty days after the
				disciplinary decision is issued; or
(9) Submitting to or filing with the director
				any notice, statement, or other document required under this chapter, which is
				false or untrue or contains any material misstatement or omission of
				fact.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-22 - Opportunity for review of revocation or suspension of the medical review officer license

Current through June, 2024
(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 receipt requested. The notice shall state
				the following:
(1) The reasons for the
				suspension or proposed revocation;
(2) The terms of the suspension or proposed
				revocation; and
(3) The period of
				suspension or proposed revocation.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-23 - Relicensing of medical review officer

Current through June, 2024
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 suspension or
				  revocation, the director may relicense the individual.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-24 - Renewal of medical review officer license

Current through June, 2024
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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-25 - Responsibilities of medical review officer

Current through June, 2024
(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 receive from the laboratory negative test
				results.
(b) For each positive test
				result, the medical review officer shall determine whether the result can be
				attributable to factors other than substance abuse. The medical review officer
				is responsible for the following actions:
(1)
				Consult with the laboratory officials if necessary.
(2) Request, if needed, a quantitative
				description of test results.
(3)
				Inform the tested individual of the test results.
(4) Offer to conduct a medical interview with
				the tested individual, but not necessarily face to face.
(5) Review the individual's medical history
				or any other relevant biomedical factors which the individual has
				provided.
(6) Order a re-analysis
				of the original specimen by a laboratory if necessary.
(7) Consult with the third party, if
				necessary.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-26 - Shipping of specimens

Current through June, 2024
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
				  sender shall sign and enter the date of sealing in the container for shipment.
				  The appropriate chain of custody documentation shall be attached to each
				  container sealed for shipment to the substance abuse testing
				  laboratory.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-27 - Chain of custody

Current through June, 2024
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 collection
				  to the receipt by the laboratory and that upon receipt by the laboratory an
				  appropriate laboratory chain of custody form be used for the specimen or
				  specimen aliquot within the laboratory. Chain of custody forms shall, at a
				  minimum, include an entry documenting date and purpose each time a specimen or
				  aliquot is handled or transferred and identifying every individual in the chain
				  of custody. The chain of custody of the collecting site shall contain the
				  "coded" identity of the individuals being tested. The laboratory chain of
				  custody shall either use the coded identity of the collection site, or the
				  accessioning number assigned by the laboratory, in which case laboratory chain
				  of custody shall contain both the code and accessioning
				  number.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-29 - Reports

Current through June, 2024
(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 negative specimens on both the initial and
				confirmatory tests.
(3) The name
				and address of the laboratory.
(4)
				Any additional information concerning the tests.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-30 - Transmittal of reports

Current through June, 2024
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 transmission
				  and limit access to any data transmission, storage, and retrieval
				  system.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-31 - Licensing fees

Current through June, 2024
(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
150.00
Provisional license
150.00
150.00
150.00
(b)
				Fees are non-refundable.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-32 - Confidentiality

Current through June, 2024
(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 any other method of discovery, except that information related to a
				positive test result of an individual shall be disclosed to the individual, the
				third party, or the decision maker in a lawsuit, grievance, or other proceeding
				initiated by or on behalf of the individual tested and arising from positive
				confirmatory test result.
(b) Any
				person who receives or comes into possession of any information protected under
				this chapter shall be subject to the same obligation of confidentiality as the
				party from whom the information was received.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-33 - Remedies

Current through June, 2024
(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 court, which penalty and costs shall be paid to the aggrieved person. This
				subsection shall not be construed as limiting the right of any person or
				persons to recover actual damages.
(b) In addition to any other enforcement
				mechanism allowed by law, any person, agency, or entity that commits, or
				proposes to commit, any act in violation of this chapter may be enjoined
				therefrom by a court of competent jurisdiction. An action for injunctive relief
				under this subsection may be brought by any aggrieved person that will fairly
				and adequately represent the interests of the protected class.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 113 - SUBSTANCE ABUSE TESTING BY LABORATORIES › Section 11-113-34 - Severability clause

Current through June, 2024
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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 114 - TESTING OF BLOOD, BREATH, AND OTHER BODILY SUBSTANCES FOR ALCOHOL CONCENTRATION › Subchapter 1 - GENERAL PROVISIONS › Section 11-114-1 - Purpose and applicability of chapter

Current through June, 2024
(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 collect samples for or conduct forensic alcohol testing for
				  the purpose of introduction of the alcohol test results into evidence in either
				  civil or criminal proceedings under applicable State driving under the
				  influence of alcohol statutes.
(c)
				  Laboratories, personnel, and breath alcohol testing facilities of the federal
				  government are exempt from the provisions of this chapter except as required by
				  federal statute or policy.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 114 - TESTING OF BLOOD, BREATH, AND OTHER BODILY SUBSTANCES FOR ALCOHOL CONCENTRATION › Subchapter 1 - GENERAL PROVISIONS › Section 11-114-2 - Compliance

Current through June, 2024
Nothing in this chapter shall be construed as limiting the
					 introduction in any legal proceeding of relevant evidence of the alcohol
					 concentration of a person's blood, breath, or other bodily substance not
					 obtained in strict compliance with the requirements of this chapter provided
					 that the evidence is offered in compliance with the Hawaii rules of
					 evidence.