reglab/statecodes huggingface dataset:
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 103.1 - LICENSURE AND CERTIFICATION FEES FOR HEALTH CARE FACILITIES AND AGENCIES › Exhibit B

Current through June, 2024
HAR CHAPTER 11-103.1
Licensure and Certification Renewal Fee Schedule
5/1/22
Facility or Service
Licensure and Certification Renewal
							 Fee (in $USD)
Adult Day Care Center
700
Adult Residential Care Home Type I
225
Adult Residential Care Home Type II
225
Assisted Living Facility
500
Broad Service Hospital or Hospital
1,000 plus
10 per bed
Clinical Laboratory
100
Community Care Foster Family Home
125
Developmental Disability Domiciliary
							 Home
225
Expanded Adult Residential Care Home Type
							 I
225
Expanded Adult Residential Care Home Type
							 II
225
Freestanding Adult Day Health Center
1,000
Freestanding Birthing Center
1,000
Freestanding Outpatient Surgical
							 Facility
2,500
Home and Community Based Case Management
							 Agency
125
Home Care Agency
1,000
Home Health Agency
2,000
Intermediate Care Facility for Individuals with
							 Intellectual Disabilities
700 plus
10 per bed
Intermediate Care Facility (ICF), Skilled Nursing
							 Facility (SNF), ICF/SNF, or Nursing Facility (NF)
700 plus
10 per bed
Special Treatment Facility
250
Therapeutic Living Program
250
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 1 - GENERAL PROVISIONS › Section 11-104.1-1 - Purpose

Current through June, 2024
The purposes of these rules, which shall be known as the
					 Hawaii Rules for Management and Disposal of Infectious Waste, are to:
(1) Implement section
				  321-21,
				  Hawaii Revised Statutes ("HRS"); and
(2) Establish minimum requirements for the
				  management, treatment, transport, storage and disposal of infectious waste and
				  treated infectious waste in order to ensure practices that will protect the
				  health and safety of persons living in Hawaii. These rules are not intended and
				  shall not be construed to lower the standards and requirements found in
				  ordinances, codes, or rules established by the department or other government
				  agencies. In all instances, the more stringent rules shall apply.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 1 - GENERAL PROVISIONS › Section 11-104.1-3 - Prohibited acts

Current through June, 2024
No person shall handle, treat, dispose of, transport, or
					 store infectious waste or treated infectious waste except in accordance with
					 these rules. Any infraction of this section shall be subject to administrative
					 penalties or fines as set forth in section
					 11-104.1-42.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 1 - GENERAL PROVISIONS › Section 11-104.1-4 - Categories of infectious waste

Current through June, 2024
(a) Categories of
				  infectious waste are as follows:
(1)
				  Infectious isolation waste;
(2)
				  Cultures and stocks of infectious agents;
(3) Blood, blood products, and other
				  body-fluids;
(4) Human pathological
				  waste;
(5) Contaminated sharps;
				  and
(6) Animal waste.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 2 - UNTREATED INFECTIOUS WASTE IN A GENERATING FACILITY › Section 11-104.1-11 - Handling of untreated infectious waste within a generating facility

Current through June, 2024
(a) Infectious waste shall be segregated from
				  all other waste at the point of generation.
(b) The types of untreated infectious waste
				  described in section 11-104.1-4 shall be managed as follows:
(1) Infectious isolation waste, cultures and
				  stocks of infectious agents, blood, blood products, and other body fluids
				  considered infectious, and human pathological waste shall be deposited at the
				  point of generation into containers lined with nonsoluble plastic bags which
				  are clearly marked with the Universal Biological Hazard symbol, or into red
				  plastic bags.
(A) All plastic bags shall be
				  sufficient in number and thickness to securely contain the waste completely;
				  and
(B) All bags shall be tightly
				  closed before being transported so as to contain the waste
				  completely.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 2 - UNTREATED INFECTIOUS WASTE IN A GENERATING FACILITY › Section 11-104.1-12 - Transportation of untreated infectious waste within a generating facility

Current through June, 2024
(a) Untreated infectious waste shall be
				  placed in containers sufficient to contain the waste completely. Satisfactory
				  containers include:
(1) Nonsoluble plastic
				  bags either red in color or clearly labeled with the Universal Biological
				  Hazard symbol;
(2) Sharps
				  containers as described in section 11-104.1-11(b)(2); or
(3) Sturdy leakproof containers clearly
				  marked with the Universal Biological Hazard symbol.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 2 - UNTREATED INFECTIOUS WASTE IN A GENERATING FACILITY › Section 11-104.1-13 - Storage of untreated infectious waste within a generating facility

Current through June, 2024
Infectious waste which is being stored while awaiting
					 treatment, shall be stored in disposable or reusable sturdy, leakproof
					 containers that have tight-fitting lids and the containers shall be stored in a
					 fully enclosed, secured room. Both the leakproof containers and the secured
					 room shall be clearly labeled with the Universal Biological Hazard symbol.
					 These containers shall be kept in fully enclosed, secured, and well-ventilated
					 locations which are inaccessible to animals and persons not authorized to
					 handle the treatment, transfer, or disposal of infectious waste.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 3 - TREATED INFECTIOUS WASTE › Section 11-104.1-21 - Treatment of infectious waste within a generating facility

Current through June, 2024
(a) Before disposal, infectious waste may be
				  incinerated, sterilized, or chemically disinfected on site in accordance with
				  the following:
(1) The current CDC
				  recommendations on universal precautions for prevention of transmission of HIV
				  immunodeficiency virus, hepatitis B virus and other blood borne pathogens in
				  health care settings;
(2) The
				  current EPA guide for infectious waste management;
(3) Part 1910, OSHA standards, of Title 29 of
				  the Code of Federal Regulations, Subpart Z;
(4) The current CLSI waste management
				  guidelines; and
(5) By other
				  methods approved by the aforementioned agencies or the department.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 3 - TREATED INFECTIOUS WASTE › Section 11-104.1-22 - Storage of treated infectious waste within a generating facility

Current through June, 2024
(a) Treated infectious waste that has not
				  been incinerated shall be stored in containers that are clearly marked as
				  treated waste which has been rendered noninfectious.
(b) Infectious waste that has been treated
				  and is awaiting transport for disposal shall be stored in fully enclosed,
				  sealed containers and secured areas which are accessible only to persons
				  authorized to handle their disposal.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 4 - STANDARDS FOR INFECTIOUS WASTE GENERATORS AND TRANSPORTERS › Section 11-104.1-31 - Transportation of infectious waste for treatment away from the generating facility

Current through June, 2024
(a) Infectious
				  waste shall be placed in containers which are sufficient to contain the waste
				  completely. Satisfactory containers include:
(1) Nonsoluble plastic bags, red in color or
				  clearly labeled with the Universal Biological Hazard symbol;
(2) Sharps containers as described in section
				  11-104.1-11(b)(2); or
(3) Sturdy
				  leakproof containers clearly marked with the Universal Biological Hazard
				  symbol.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 4 - STANDARDS FOR INFECTIOUS WASTE GENERATORS AND TRANSPORTERS › Section 11-104.1-32 - Disposal of untreated infectious waste and treated infectious waste

Current through June, 2024
(a) All infectious waste shall be treated in
				  accordance with these rules. Infectious waste that has not been treated at the
				  generating facility shall be released to a medical waste treatment facility as
				  permitted in accordance with chapter 11-58.1.
(b) Treated infectious waste that has not
				  been incinerated shall be stored in containers that are clearly marked as
				  treated waste which has been rendered noninfectious.
(c) All treated human body parts shall be
				  disposed of in accordance with other applicable state laws governing the
				  disposal of human remains.
(d)
				  Incinerator ash, treated infectious waste, and treatment byproducts shall be
				  disposed of only in state permitted landfills or authorized sites in accordance
				  with chapter
				  11-58.1.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 4 - STANDARDS FOR INFECTIOUS WASTE GENERATORS AND TRANSPORTERS › Section 11-104.1-33 - Infectious waste management plan

Current through June, 2024
(a) Each infectious
				  waste generator and transporter of untreated infectious waste shall have a
				  written plan that contains policies and detailed procedures that:
(1) Outline the handling, safe and effective
				  management, and disposal of infectious waste in accordance with these rules;
				  and
(2) Ensure the health and
				  safety of persons living in Hawaii and the environment in accordance with
				  applicable federal, state, and local regulations, which include, but are not
				  limited to, those regulations issued by the CDC, OSHA, EPA, and CLSI, as well
				  as chapter
				  11-58.1, chapter
				  11-62,
				  and chapter 14, Revised Ordinances of Honolulu.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 4 - STANDARDS FOR INFECTIOUS WASTE GENERATORS AND TRANSPORTERS › Section 11-104.1-34 - Exemption for placenta

Current through June, 2024
(a) Upon negative
				  findings of infection or hazard after appropriate testing of the mother by a
				  health care facility or physician and confirmation of the findings on a release
				  form established by the department, a placenta may be released by a health care
				  facility or generator to the woman from which it originated or to the woman's
				  designee.
(b) The health care
				  facility or generator shall develop a procedure to ensure the safe management
				  and transport of the placenta and may follow the requirements as set forth in
				  this chapter or by the CDC, the EPA, the CLSI for clinical laboratory waste
				  management or the OSHA or other similar guidelines.
(c) The procedure for the management and
				  transport of placenta shall be set forth in writing and shall be available for
				  the department's review.
(d) The
				  release form must be signed by the mother, physician, and health care facility
				  authority. One copy of the release form shall be filed in the patient chart and
				  one copy shall be sent via facsimile transmission to the department.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 5 - ENFORCEMENT › Section 11-104.1-41 - Enforcement

Current through June, 2024
(a) If the department determines that any
				  person has violated any provision of this chapter, any provision of chapter
				  321, HRS, or any term or condition of an exemption issued pursuant to this
				  chapter, the department may:
(1) Issue an
				  order assessing an administrative penalty in accordance with section
				  321-20, HRS, for any
				  past or current violation; or
(2)
				  Require compliance immediately or within a specified period of time;
				  or
(3) Issue an order pursuant to
				  paragraph (1) and require compliance pursuant to paragraph (2).
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 5 - ENFORCEMENT › Section 11-104.1-42 - Penalties

Current through June, 2024
(a) Any person, corporation, health care
				  facility, clinic, laboratory, or agency that violates any of the provisions of
				  this chapter shall be subject to an administrative penalty not to exceed one
				  thousand dollars for each separate offense. Each day that a violation exists or
				  continues may constitute a separate offense. The violator shall also be subject
				  to the provisions of section
				  321-20, HRS and shall be
				  entitled to pursue the remedies provided therein including recourse to
				  administrative contested case proceedings in accordance with chapter 91,
				  HRS.
(b) Other than those
				  situations in which a request for an exemption is granted, the following
				  individuals and entities shall be responsible for the handling, transport,
				  treatment, storage, or disposal of any infectious waste or treated infectious
				  waste that is not in accordance with this chapter:
(1) The generator of the waste;
(2) Any person who, or entity that, by
				  contract, agreement, or otherwise has arranged to treat, store, transport, or
				  dispose of the waste; and
(3) Any
				  person who, or entity that, accepts or accepted any treated or untreated
				  infectious waste for treatment, storage, transport, or disposal.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 104.1 - MANAGEMENT AND DISPOSAL OF INFECTIOUS WASTE › Subchapter 5 - ENFORCEMENT › Section 11-104.1-43 - Severability

Current through June, 2024
If any provision of this chapter or the application
					 thereof to any person or circumstances is held invalid, the remainder of this
					 chapter, or the application of the provision to other persons or circumstances,
					 shall not be affected thereby.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 105 - FEES FOR HOME HEALTH SERVICES › Section 11-105-1 - Purpose

Current through June, 2024
The purpose of this chapter is to establish fees for home
				  health services on the islands of Lanai and Molokai provided by the Public
				  Health Nursing Branch This section implements the program of home health
				  services pursuant to the provision of Title XVIII of the Social Security
				  Act.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 105 - FEES FOR HOME HEALTH SERVICES › Section 11-105-2 - Definitions

Current through June, 2024
As used in this chapter:
"Skilled nursing services" means services provided by a
				  registered professional nurse which requires assessment of health needs, plan
				  of care, implementation of nursing intervention to effect a change in these
				  health needs and evaluation of services provided to the patient.
"Visit" means a contact with a patient at the place of
				  residence or in an office to provide skilled nursing or therapeutic services. A
				  visit is calculated at
				  1-1/2
				  hours.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 105 - FEES FOR HOME HEALTH SERVICES › Section 11-105-3 - Fees

Current through June, 2024
The following fees shall be charged as follows:
Visit Type
Molokai
Lanai
Skilled Nursing - Registered Professional Nurse
55.00
62.00
Health Aide - Ancillary paramedical services
42.00
42.00
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 106 - BACKGROUND CHECKS › Section 11-106-1 - Purpose

Current through June, 2024
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 that is
				  licensed and certified, or licensed or certified by the department, and, in the
				  case of any healthcare facility operated in a private residence, all adults
				  living in the home other than the clients, and a person or entity seeking
				  part-time or full-time employment or contract or sub-contract with the
				  department
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 106 - BACKGROUND CHECKS › Section 11-106-3 - Background checks

Current through June, 2024
(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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 106 - BACKGROUND CHECKS › Section 11-106-4 - Enforcement

Current through June, 2024
(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 the case of any healthcare facility operated in a private residence, any
				adult living in the home other than the client:
(1) Refuses to authorize the department or
				its designee to conduct a background check, refuses to authorize the department
				or its designee to obtain background check record information for verification,
				or refuses consent to be fingerprinted;
(2) Refuses or fails to submit to the
				department or its designee information required to perform a background
				check;
(3) Has any disqualifying
				information; or
(4) Has any
				background check information that the department or its designee finds may pose
				a risk to the health, safety, or welfare of the residents or patients of the
				healthcare facility.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 106 - BACKGROUND CHECKS › Section 11-106-5 - Frequency of background checks

Current through June, 2024
(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
				inquiry into the state's criminal history records on employees or contractors
				for each of the first two years of employment or contract and biennially
				thereafter to ensure continued compliance with background check
				standards.
(c) The department may
				waive the requirements of paragraph (b) of this section for employees,
				contractors, or healthcare providers or operators enrolled in the state's rap
				back program.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 106 - BACKGROUND CHECKS › Section 11-106-6 - Exemption from disqualifying information

Current through June, 2024
(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 chapter shall follow procedures specified by the
				department.
(b) Requests for
				exemptions shall be made in writing within thirty calendar days of applicant's
				receipt of background check results.
(c) The department or its designee shall not
				accept future background check applications for one calendar year from any
				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, who is determined to have
				disqualifying information, fails to submit a request for exemption from
				disqualifying information within thirty calendar days of the receipt of
				background checks results.
(d) The
				department or its designee may accept future background check applications
				within one calendar year from any 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, who
				is determined to have disqualifying information, if the disqualifying
				information is not relevant to the job description or scope of
				employment.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 106 - BACKGROUND CHECKS › Section 11-106-7 - Decision

Current through June, 2024
(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
				department's decision and the right to an administrative appeal pursuant to
				chapter
				91, HRS and chapter
				11-1, HAR.
(b) The right to an administrative appeal of
				the department's or its designee's decision shall be as set forth in the rules
				for the program under which the applicant is seeking licensure.
(c) When an administrative appeal is
				requested to contest a decision to deny, revoke, or suspend a license or
				certificate pursuant to this chapter, a healthcare facility shall not operate,
				or an employee or prospective employee shall not work at the healthcare
				facility, pending the completion of the appeal.
(d) A hearing under this section shall be
				conducted as a contested case hearing under chapter
				91, HRS, and in accordance with
				chapter
				11-1, HAR."
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 1 - GENERAL PROVISIONS › Section 11-110.1-1 - Purpose

Current through June, 2024
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.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 1 - GENERAL PROVISIONS › Section 11-110.1-3 - Variances and waivers

Current through June, 2024
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 innovative approaches to delivery of services, where
				  the approach has the potential to improve service delivery; or
(2) Strict application would cause undue
				  hardship and equivalent standards affording protection of health, safety, and
				  care exist and will be met in lieu of the exact rule requirements.
Hawaii Administrative Rules › Title 11 - DEPARTMENT OF HEALTH › Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS › Chapter 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 1 - GENERAL PROVISIONS › Section 11-110.1-4 - 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 110.1 - CLINICAL LABORATORIES AND LABORATORY PERSONNEL › Subchapter 2 - CLINICAL LABORATORIES › Section 11-110.1-5 - Applicability of subchapter 2 and exemptions

Current through June, 2024
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 CLIA pursuant to 42 C.F.R. part 493 subpart A and operated by a licensed
				  physician at a stated location where clinical laboratory tests are performed
				  exclusively for the physician's own patients. The licensed physician shall
				  serve as the laboratory director for this laboratory. Such clinical
				  laboratories shall comply with section 11-110.1-16(e);
(4) Operated by a police department of any
				  county and perform breath alcohol analysis;
(5) Certified as a clinical laboratory under
				  42 C.F.R. part 493 subpart A and perform laboratory testing for pulmonary
				  function in a licensed medical facility; or
(6) Conducting any study of public health
				  importance with the written approval of the director.
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 11-110.1-6 - Requirements for a clinical laboratory permit or license

Current through June, 2024
(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 are
				  performed.
(c) The following
				  laboratories shall be exempt from the requirements of subsection (b):
(1) Clinical laboratories located within
				  contiguous buildings in a hospital, share the same address, and under the
				  direction of the same laboratory director may apply for a single license or
				  permit.
(2) Laboratories that are
				  not at a fixed location, that is, laboratories that move from testing site to
				  testing site, such as mobile units providing laboratory testing, health
				  screening fairs, or other temporary testing locations may be covered under the
				  license or permit of the designated primary site or home base, using the
				  address of the primary site or home base.
(3) Not-for-profit or State or local
				  government laboratories that engage in limited (not more than a combination of
				  fifteen PPMPs, POCTs or waived tests per license or permit) public health
				  testing may file a single application.
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 11-110.1-7 - Requirements for a class I clinical laboratory permit

Current through June, 2024
(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 laboratory under 42 C.F.R. part 493 subpart A;
				  and
(3) Remits applicable
				  fees.
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 11-110.1-8 - Requirements for a class II clinical laboratory permit

Current through June, 2024
(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 only waived,
				  PPMP tests, or POCTs or a combination of these tests;
(4) Is certified as a clinical laboratory
				  under 42 C.F.R. part 493 subpart A; and
(5) Remits applicable fees.
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 11-110.1-9 - Requirements for a clinical laboratory license

Current through June, 2024
(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 waived, PPMPs, or POCTs;
				  and
(3) Remits applicable
				  fees.
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 11-110.1-10 - Licensed clinical laboratory; clinical laboratory director's responsibilities

Current through June, 2024
(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
				  active participation in the operations to the extent necessary to assure
				  compliance with the rules and directives of the department;
(2) The proper performance of all tests in
				  the laboratory; and
(3) The
				  technical supervision of qualified laboratory personnel.
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 11-110.1-11 - Licensed clinical laboratory; personnel requirements

Current through June, 2024
(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-licensed clinical
				  laboratory personnel may perform waived, PPMPs, and POCTs. All other laboratory
				  procedures, not including preparatory portions, shall be performed by
				  appropriately licensed clinical laboratory personnel.
(c) An adequate number of qualified personnel
				  shall be provided for the volume and complexity of procedures and tests
				  performed.
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 11-110.1-12 - Licensed clinical laboratory; specimen identification and examination

Current through June, 2024
(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
				  pathologist who is certified, or eligible for certification, in anatomic
				  pathology by the American Board of Pathology or a physician who has
				  demonstrated to the satisfaction of the department that he or she has the
				  equivalent of such certification.
(c) Every abnormal specimen for exfoliative
				  cytology shall be examined and reported upon by a qualified
				  pathologist.
(d) Initial
				  examination or "screening" of specimens for exfoliative cytology and reporting
				  of negative gynecologic specimens, may be made by a person who is licensed as a
				  cytotechnologist.
(e) Every
				  laboratory shall have a written and documented procedure to assure that an
				  appropriate number of negative gynecological specimens are
				  reevaluated.
(f) If the component
				  to be tested in a specimen is perishable, labile, or otherwise subject to
				  deterioration, the specimen shall be tested promptly after collection. If a
				  specimen is transported or stored, it shall be properly preserved,
				  refrigerated, frozen, or otherwise appropriately treated to maintain it in as
				  close to its original state as allowed by current technology.
(g) Every clinical laboratory shall promptly
				  notify the sender of any specimen that is not satisfactory for testing for any
				  reason.
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 11-110.1-13 - Licensed clinical laboratory; records

Current through June, 2024
(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
				  contain the following information:
(1) The
				  laboratory number or other identification of each specimen received by the
				  laboratory;
(2) The name or other
				  unique identification of the person from whom the specimen was taken;
(3) The name of the person or clinical
				  laboratory who submitted the specimen;
(4) If the request for the test was oral and
				  not followed by a written request, a written statement to that effect shall be
				  made;
(5) The date and time, if
				  applicable, the specimen was collected;
(6) The date and time the specimen was
				  received by the clinical laboratory;
(7) If the specimen is forwarded to another
				  laboratory, the name of the other laboratory, the date the specimen was
				  forwarded to the other laboratory, the date it was tested, and the date the
				  report of the findings of the tests was received from the other
				  laboratory;
(8) The condition of
				  unsatisfactory specimens when received (e.g., broken, leaked, hemolyzed,
				  turbid, etc.);
(9) The actual tests
				  performed;
(10) The results of the
				  laboratory tests or cross reference to results;
(11) The date a report was sent to the
				  department pursuant to section 11-110.1-16(e); and
(12) The name, the initials, or other
				  identification of the person who performed each test, or in the case of a test
				  involving performance by more than one person, the name, the initials, or other
				  identification of the persons who actually supervised the test.
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 11-110.1-14 - Licensed clinical laboratory; proficiency testing and quality assessment programs

Current through June, 2024
(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 laboratory. All licensed clinical laboratories
				  are required to demonstrate and maintain proficiency in each of the specialties
				  or subspecialties for which it is licensed.
(b) Each licensed clinical laboratory shall
				  maintain a properly documented quality assessment program that is acceptable to
				  the department. The quality assessment program shall be designed to assure, on
				  a continuous basis, the reliability of all laboratory results. All facilities,
				  equipment, and instruments shall have inherent capabilities consistent with the
				  services offered and shall be maintained in good operating condition.
(c) Each licensed clinical laboratory shall
				  maintain a written preventive maintenance program which details periodic
				  inspection for proper operation of each piece of equipment and instrument, a
				  written program for validation and calibration of equipment, a dependable
				  reagent and glassware evaluation system, and a continuous surveillance of
				  results. Appropriate records showing the dates of inspections, validation,
				  evaluation, and significant actions taken in response to revealed defects,
				  shall be maintained.
(d) Current
				  manuals of methods and technical procedures shall be maintained by the
				  laboratory and shall be made available to clinical laboratory personnel and,
				  for inspection, to representatives of the department.
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 11-110.1-15 - Limitations

Current through June, 2024
(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 specialties or
				  subspecialties which the clinical laboratory director or testing personnel are
				  qualified to perform. The clinical laboratory director shall notify and seek
				  approval from the department in writing of any changes of specialties or
				  subspecialties at least thirty days prior to the occurrence of each
				  change.
(c) No clinical laboratory
				  license may include the specialty of anatomic pathology or cytology unless
				  tissue specimens or specimens for cytologic examinations are to be examined on
				  the premises by a pathologist or a physician who has demonstrated to the
				  satisfaction of the department that he or she is qualified by education,
				  training, and experience to perform such procedures pursuant to 42 C.F.R. part
				  493.
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 11-110.1-16 - Licensed clinical laboratories and laboratories with class I or class II permits: clinical laboratory procedures

Current through June, 2024
(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 director. Each change in a
				  procedure shall be approved, signed, and dated by the laboratory
				  director.
(b) Except as otherwise
				  provided in this chapter, a clinical laboratory shall examine specimens only at
				  the request of an authorized person.
(c) The result of a test shall be reported
				  only to the authorized person who ordered the test and the designee(s) of the
				  person who ordered the test. No diagnosis or treatment may be made part of the
				  laboratory report, except for reports made by a licensed physician if such
				  reports are-signed by the physician.
(d) All specimens accepted by a clinical
				  laboratory shall be tested on its premises. However, specimens for infrequently
				  performed tests, or those not included within its permit or specialties stated
				  on its license, or those requiring specialized equipment and skill, may be
				  forwarded to another laboratory acceptable to the department. The reports of
				  the results of such tests shall be sent by the testing laboratory to the
				  forwarding clinical laboratory. The forwarding laboratory shall send a copy of
				  such reports to the authorized person requesting the test, and shall indicate
				  thereon the name and address of the laboratory in which the test was actually
				  performed.
(e) The clinical
				  laboratory director shall report to the department all laboratory findings
				  which indicate the presumptive presence of any disease required to be reported
				  pursuant to chapter
				  11-156, entitled "Communicable
				  Diseases," or as required by other statutes or rules.
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 11-110.1-17 - Licensed clinical laboratories and laboratories with class I or class II permits: safety and sanitation requirements

Current through June, 2024
(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
				  well-ventilated, well-lighted, and, if needed for laboratory testing, have a
				  sink with running water and convenient access to gas, suction, or properly
				  grounded electrical outlets. There shall be sufficient space to perform the
				  services provided by the laboratory with optimum accuracy and safety.
(c) All culture processes involving potential
				  sources of aerosolized pathogens shall be performed in a biological safety
				  cabinet. All procedures which involve liberation of toxic, corrosive, or
				  explosive substances shall be performed in a fume hood.
(d) Cylinders of compressed gases shall be
				  secured in a manner to prevent falling or being knocked over.
(e) Blood and blood components used for
				  transfusion shall be stored and maintained at a temperature indicated on the
				  product label. This shall be verified continuously by a recording thermometer
				  and confirmed by a system of audible and visible alarms which are monitored at
				  all times. Stored blood shall be inspected daily.
(f) Flammable or combustible liquids shall be
				  stored in compliance with applicable state and federal standards.
(g) Laboratories using corrosive materials
				  shall have appropriately located safety showers and eye wash
				  stations.
(h) Adequate numbers and
				  appropriate types of fire extinguishers shall be placed in convenient
				  locations, inspected at least annually, and recharged if necessary.
(i) Syringes, needles, lancets, or other
				  blood drawing devices shall be decontaminated and disposed of in compliance
				  with 29 C.F.R. part 1910.1310 and chapter 11-104.1.
(j) Diagnostic use of radioactive isotopes
				  shall conform to the laws of the State and the regulations of the United States
				  Nuclear Regulatory Commission.
(k)
				  Cultures and specimens and all other potentially infectious materials shall be
				  decontaminated in accordance with chapter 11-104.1, prior to
				  disposal.
(l) All personnel
				  handling open specimens shall wear protective clothing and other safety gear as
				  is necessary.
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 11-110.1-18 - Collecting depot

Current through June, 2024
(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 procedures used to ensure the satisfactory
				  collection of specimens including patient preparation prior to specimen
				  collection, proper specimen identification, and storage and preservation of
				  specimens;
(2) Collect specimens
				  only at the request of authorized persons;
(3) Be adequate for the proper collection of
				  specimens. This shall include adequate and proper staffing, plumbing, heating,
				  cooling, lighting, ventilation, refrigeration, electrical services, sanitary
				  conditions, fire protection within the collecting depot and its surroundings,
				  water supply, sewage disposal, procedures for handling and disposal of
				  specimens, and safety measures for personnel;
(4) Keep and maintain a record indicating the
				  daily accession of specimens. The record shall contain the following
				  information:
(A) The name or other unique
				  identification of the person from whom the specimen was taken;
(B) The name of the person who requested the
				  test;
(C) The date and time when
				  the specimen was received or when it was collected;
(D) Signature or suitable identification of
				  the person receiving or collecting the specimen;
(E) The type or source of the specimen;
				  and
(F) The test(s)
				  requested.
(5) The
				  results of a test shall be reported only to the person described in
				  paragraph(2).
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 11-110.1-19 - Unlawful practices

Current through June, 2024
(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 certified under 42 C.F.R. part 493 subpart A or a collecting depot
				  conducted in conformity with section 11-110.1-18 shall receive specimens for
				  the purpose of laboratory examination to obtain information for diagnosis,
				  prevention, or treatment of a disease or the assessment of a medical condition.
				  Clinical laboratories operating outside the State shall receive clinical
				  specimens collected in the State only at the request of an authorized
				  person.