"Medical Marijuana Testing Facility Application Form" - Hawaii

Medical Marijuana Testing Facility Application Form is a legal document that was released by the Hawaii Department of Health - a government authority operating within Hawaii.

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Download "Medical Marijuana Testing Facility Application Form" - Hawaii

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VIRGINIA PRESSLER, M.D.
DAVID Y. IGE
DIRECTOR OF HEALTH
GOVERNOR OF HAWAII
STATE OF HAWAII
DEPARTMENT OF HEALTH
In reply, please refer to:
STATE LABORATORIES DIVISION (SLD)
A. Christian Whelen
File: SLD/ADMIN
SLD Administrator
2725 WAIMANO HOME ROAD
PEARL CITY, HAWAII 96782-1496
Medical Marijuana Testing Facility Application
Legal Name of Laboratory or Facility
Facility Address (physical location of testing)
Mailing Address if different from physical location
Name of Director or Manager
(person responsible for laboratory results)
Telephone:
Fax Number:
E-mail address:
Contact Person
Telephone:
Fax Number:
E-mail address:
Quality Assurance Officer
Telephone:
Fax Number:
E-mail address:
1.
Area(s) of Interest: Check all that apply
Area
Minimum Required Analytes
Chemistry – Potency
(Delta 9)-Tetrahydrocannabinol (THC)
Tetrahydrocannabinol Acid (THCA)
EHASB_BR_ADM_Medical_Marijuana_Testing_Facility_Application1v1.pdf
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VIRGINIA PRESSLER, M.D.
DAVID Y. IGE
DIRECTOR OF HEALTH
GOVERNOR OF HAWAII
STATE OF HAWAII
DEPARTMENT OF HEALTH
In reply, please refer to:
STATE LABORATORIES DIVISION (SLD)
A. Christian Whelen
File: SLD/ADMIN
SLD Administrator
2725 WAIMANO HOME ROAD
PEARL CITY, HAWAII 96782-1496
Medical Marijuana Testing Facility Application
Legal Name of Laboratory or Facility
Facility Address (physical location of testing)
Mailing Address if different from physical location
Name of Director or Manager
(person responsible for laboratory results)
Telephone:
Fax Number:
E-mail address:
Contact Person
Telephone:
Fax Number:
E-mail address:
Quality Assurance Officer
Telephone:
Fax Number:
E-mail address:
1.
Area(s) of Interest: Check all that apply
Area
Minimum Required Analytes
Chemistry – Potency
(Delta 9)-Tetrahydrocannabinol (THC)
Tetrahydrocannabinol Acid (THCA)
EHASB_BR_ADM_Medical_Marijuana_Testing_Facility_Application1v1.pdf
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Cannabidiol (CBD)
Cannabidiolic Acid (CBDA)
Cannabigerol (CBG)
Cannabinol (CBN)
Chemistry – Heavy Metals
Arsenic
Lead
Cadmium
Mercury
Chemistry - Pesticides
Pesticides that are regulated by EPA
(the U.S. Environmental Protection Agency)
Chemistry – Solvents
Butanes
Heptanes
Benzene
Toluene
Hexane
Total Xylenes (m, o, p-xylene)
Alcohols (e.g., methanol, ethanol, etc.)
Ketones (e.g., acetone)
Chemistry – Moisture Content
Moisture content of plant material
Microbiology
Total viable Aerobic Bacteria Count
Total Yeast and Mold
Total Coliform Bacteria
Bile-tolerant Gram Negative Bacteria
E. coli (pathogenic strains)
Salmonella species
Aspergillus fumigatus
Aspergillus flavus
Aspergillus niger
Mycotoxins
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2.
Current International Standards for Organization (ISO) 17025 Status for the laboratory:
ISO 17025 Accredited
Parent company ISO 17025 Accredited
Applied for ISO 17025 Accreditation (minimum requirement)
3.
Submit electronic versions of the following documents with this application: (e.g., on a USB thumb
drive):
A.
Management Systems
Management System documentation including, but not limited to: a laboratory organization
chart including the identification of key personnel by name, lines of authority and
responsibilities of personnel, Organizational plans, mission, goals, and objectives,
Management objective and the laboratory's administrative policies and procedures,
continuous improvement strategy and methods; including systematic monitoring and
change management and Management controls to ensure consistent performance.
If this laboratory is part of a larger organization, a chart indicating this laboratory’s position
within the larger organization and the reporting relationships within the organization.
B.
Security
A written security policy that describes the methods and devices that will be used to
provide security for the medical marijuana samples in the laboratory.
C.
Facilities
A description of the facilities and equipment that shall be used in the operation of the
testing laboratory.
Equipment information including the type of equipment used in medical marijuana testing,
performance checks and function verification, testing and calibration schedules,
maintenance, and representative records. Include the identification of external
maintenance and calibration services if applicable.
D.
Employees
A list of employees of the laboratory including their education, qualifications and
experience.
Training documentation for each employee of the laboratory performing technical and / or
administrative procedures. Documentation must include subjects, acknowledgements by
trainers And analyst, and the date, time, and place of training.
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Documentation that analysts are proficient in the analytical / administrative procedures
(initial, 6 months, and annual thereafter). Documentation must include subjects,
acknowledgements by trainers and analyst, and the date, time, and place of assessment.
E.
Procedures
A list of the method(s) and products used for each medical marijuana analyte. Include the
reference and performance characteristics of each method.
Documentation demonstrating that the analytical methods used by the laboratory are
appropriate for their intended purpose.
Standard Operating Procedures used by the facility, including but not limited to: statistically
representative sampling, sample preparation, reagent and reference standard preparation;
the instrument operation; technical procedures and quality control criteria to be used in
performing the analysis for each analyte; data recording and calculation of results; data
review, storage and reporting.
Sample management including chain of custody, receipt, rejection, handling, storage and
disposition of samples of usable medical marijuana.
F.
Quality Systems
Quality Assurance (QA) Manual that includes but is not limited to the QA Plan, QA Policies
and QA Procedures to be followed by the laboratory.
Most recent Proficiency Test (PT) studies for each analyte, including the date of the PT,
the score and any corrective action(s) taken, if required.
The laboratory’s most recent inspection(s) by their accreditation body (ideally to ISO 17025
standard) and the laboratory’s responses to any findings of non-compliance with standards
or recommendations.
The laboratory’s accreditation in Hawaii or another jurisdiction, accompanied by the scope
of accreditation.
G.
Mailing / Delivery Address
Deliver or send all required materials by certified mail to State Laboratories Division, 2725
Waimano Home Road, Pearl City, Hawaii, 96782.
Name of person completing application:
Please print legibly
Signature
Date
NOTE:
Upon notification by DOH of meeting the requirements for certification, applicants must submit
a certification fee of $3000.00 (certified check, cashier’s check, or money order only; please no personal or
company check) payable to State of Hawaii Department of Health before DOH will issue the certificate.
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