reglab/statecodes huggingface dataset:
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4) › Section 216-RICR-60-05-4.7 - Denial, Suspension or Revocation of License

Current through June 14, 2024
A. In
				  addition to those grounds stated in R.I. Gen. Laws §
										23-16.2-7(a),
				  the licensing agency may deny, revoke, or suspend the license of any clinical
				  laboratory or station for engaging in conduct that includes, but is not limited
				  to, the following:
1. Failure to comply with
				  the rules and regulations in this Part and any state or federal regulations or
				  statutes;
2. Making false or
				  deceptive representation of any testing results and reports thereof;
3. Not abiding by the statutory provisions of
				  the Confidentiality of Health Care Communications and Information Act, R.I.
				  Gen. Laws Chapter 5-37.3;
4.
				  Engaging in false or deceptive advertising;
5. Making false or deceptive representation
				  on any application for licensure or renewal thereof; and/or
6. Failure to maintain prevailing standards
				  of laboratory practice that may be considered grounds for licensure suspension,
				  revocation, or curtailment of activities or other disciplinary action at the
				  discretion of the Director.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4) › Section 216-RICR-60-05-4.8 - Organization and Management

Current through June 14, 2024
4.8.1
Governing Body and Management
A.
				  Each clinical laboratory and/or station shall have a governing body or
				  equivalent legal authority ultimately responsible for:
1. The management and control of the
				  operation;
2. The assurance of the
				  quality of services;
3. The
				  compliance with all federal, state and local laws and regulations; and
4. Compliance with other relevant
				  health and safety requirements, including the rules and regulations of this
				  Part.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4) › Section 216-RICR-60-05-4.9 - Quality Assurance Program

Current through June 14, 2024
4.9.1
General
				  Requirements
Each clinical laboratory or station shall have clearly
					 established internal and external quality control programs to ensure high
					 standards of performance and reliability of test results. These programs shall
					 consider such factors as preventive maintenance, periodic inspection, testing
					 for proper operation of equipment and instruments as may be appropriate,
					 validation of methods, evaluation of reagents and volumetric equipment,
					 surveillance results, remedial action taken to correct deficiencies and such
					 other relevant factors as required in these rules and regulations and as may be
					 deemed necessary.
4.9.2
Procedural Manual
A. Each
				  clinical laboratory shall have available at all times in the immediate bench
				  area of personnel engaged in conducting clinical laboratory testing, a
				  procedure manual that includes a detailed compilation of all automated and
				  manual methods and procedures for all clinical tests that are performed by the
				  laboratory and for which it is licensed. Furthermore, such manual shall:
1. Contain information concerning preparation
				  and storage of reagents, control and calibration procedures and pertinent
				  literature references;
2. Describe
				  the laboratory's technical procedures for the collection, processing and
				  examination of specimens based on current standards of practice;
3. For those tests that are normally
				  performed on automated test equipment, provide for alternate methods or for
				  storage of the test specimens, in the event the automated equipment becomes
				  inoperable; and
4. Procedures shall
				  be approved, signed, and dated by the laboratory director. Procedures shall be
				  re-approved, signed and dated if the directorship of the laboratory changes.
				  Each change in a procedure shall be approved, signed, and dated by the current
				  director of the laboratory.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 4 - Clinical Laboratories and Stations (216-RICR-60-05-4) › Section 216-RICR-60-05-4.11 - Practices and Procedures, and Violations

Current through June 14, 2024
4.11.1
Variance Procedure
A. The
				  licensing agency may grant a variance either upon its own motion or upon
				  request of the applicant from the provisions of any rule or regulation in a
				  specific case if it finds that a literal enforcement of such provision will
				  result in unnecessary hardship to the applicant and that such variance will not
				  be contrary to the public interest, public health and/or health and safety of
				  patients. The provisions of this section shall not be applicable to the
				  requirements of §§4.8.2(A) and (B) of this Part pertaining to the
				  director of the clinical laboratory.
B. A request for a variance shall be filed by
				  an applicant in writing setting forth in detail the basis upon which the
				  request is made.
1. Upon the filing of each
				  request for variance with the licensing agency and within a reasonable time
				  thereafter, the licensing agency shall notify the applicant by certified mail
				  of its approval or in the case of a denial, a hearing date, time and place may
				  be scheduled if the station or clinical laboratory appeals the
				  denial.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.1 - Authority

Current through June 14, 2024
These regulations are promulgated pursuant to the authority
					 conferred under R.I. Gen. Laws §
										23-16.2-5(a),
					 and are established for applying minimum standards for certification of
					 analytical laboratories that analyze potable water, non-potable water, or other
					 environmental matrices for the protection of the health, safety, and welfare of
					 the public. The proper operation of analytical laboratories within the state is
					 a matter of vital concern to the health and safety of the state. The
					 determination and enforcement of proper standards is necessary to ensure the
					 qualifications and competence of personnel and to ensure the adequacy of
					 equipment, facilities, and quality assurance programs.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.2 - Incorporated Materials

Current through June 14, 2024
A. These regulations
				  hereby adopt and incorporate 40 C.F.R. Parts 122, 136, 141, 143, 430, 455, and
				  465 (July 1, 2003) by reference, not including any further editions or
				  amendments thereof and only to the extent that the provisions therein are not
				  inconsistent with these regulations.
B. These regulations hereby adopt and
				  incorporate  40 C.F.R. Part 136, Docket Number EPA-HQ-OW- 2010-0192 (March 6,
				  2013) by reference, not including any further editions or amendments thereof
				  and only to the extent that the provisions therein are not inconsistent with
				  these regulations.
C. These
				  regulations hereby adopt and incorporate EPA Solutions to Analytical Chemistry
				  Problems with Clean Water Act Methods, EPA 821-R- 07-002 (March 2007) by
				  reference, not including any further editions or amendments thereof and only to
				  the extent that the provisions therein are not inconsistent with these
				  regulations.
D. These regulations
				  hereby adopt and incorporate EPA Manual for the Certification of Laboratories
				  Analyzing Drinking Water, Fifth Edition, EPA 815-R- 05-004 (January 2005) by
				  reference, not including any further editions or amendments thereof and only to
				  the extent that the provisions therein are not inconsistent with these
				  regulations.
E. These regulations
				  hereby adopt and incorporate EPA Supplement 1 to the Fifth Edition of the
				  Manual for the Certification of Laboratories Analyzing Drinking Water. EPA
				  815-F- 08-006 (June 2008) by reference, not including any further editions or
				  amendments thereof and only to the extent that the provisions therein are not
				  inconsistent with these regulations.
F. These regulations hereby adopt and
				  incorporate APHA Standard Methods for the Examination of Water and Wastewater,
				  American Public Health Association, 18th - 22nd editions ( 1992-2012) by
				  reference, not including any further editions or amendments thereof and only to
				  the extent that the provisions therein are not inconsistent with these
				  regulations.
G. These regulations
				  hereby adopt and incorporate Methods for the Chemical Analysis of Water and
				  Wastes, U.S. Environmental Protection Agency, EPA-600/ 4-79-020 (March 1983) by
				  reference, not including any further editions or amendments thereof and only to
				  the extent that the provisions therein are not inconsistent with these
				  regulations.
H. These regulations
				  hereby adopt and incorporate Methods for the Organic Chemical Analysis of
				  Municipal and Industrial Wastewater, USEPA, EPA 600/ 4-82-057 (July 1982) by
				  reference, not including any further editions or amendments thereof and only to
				  the extent that the provisions therein are not inconsistent with these
				  regulations.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.4 - Certification

Current through June 14, 2024
5.4.1
General Requirements
A. It shall be unlawful for any analytical
				  laboratory to perform testing or analyses of samples originating in this state,
				  for which the Department requires certification, without obtaining
				  certification pursuant to the Act and this Part.
B. Certification for specific analytes and
				  methods shall be required for laboratory testing of potable water, non-potable
				  water, and environmental samples for lead content. Certification for potable
				  water is required whenever a laboratory performs analytical tests on drinking
				  water supply samples. Certification for non-potable water is required whenever
				  a laboratory performs analytical tests on water other than drinking
				  water.
C. Certification is required
				  for laboratories performing environmental lead analysis in accordance with the
				  rules and regulations for Lead Poisoning Prevention (Part 50-15-3 of this
				  Title). A certificate for environmental lead analysis shall be issued only to
				  laboratories providing documentation of accreditation through a program
				  recognized by the EPA's National Environmental Lead Laboratory Accreditation
				  Program (e.g., A2LA or AIHA).
D. An
				  analytical laboratory shall represent itself in its advertisements,
				  publications, or other forms of communication, as providing only those services
				  for which it is certified and shall not advertise in a manner that tends to
				  mislead the public.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.5 - Organization, Management, and Personnel

Current through June 14, 2024
5.5.1
Governing Body
A. Each
				  analytical laboratory shall have a governing body or equivalent legal authority
				  ultimately responsible for:
1. the management
				  and control of the operation;
2.
				  the assurance of the quality of services;
3. the compliance with all federal, state and
				  local laws and regulations; and
4.
				  compliance with other relevant health and safety requirements, including this
				  Part.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.6 - Records && Reports

Current through June 14, 2024
A. Each analytical
				  laboratory shall maintain appropriate records and reports, which shall be
				  available for inspection by authorized representatives of the
				  Department.
B. The certified
				  laboratory shall create, control, and maintain records of raw data,
				  chain-of-custody records, calculations, quality control data, and other
				  essential documentation. All records shall be complete with signatures, units
				  of measurement, and documentation sufficient for verification of results. All
				  records shall be retained in such a manner as to permit prompt retrieval. Such
				  records shall include:
1. records of the
				  operation and maintenance of all laboratory equipment;
2. records of all sample examinations in
				  accordance with § 5.7.3 of this Part;
3. records of control values, standard
				  values, calibration curves and calculations of standard deviations;
				  and
4. reports of proficiency
				  testing programs and of such other records as may be deemed
				  necessary.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.8 - Physical Plant, Equipment, and Supplies

Current through June 14, 2024
A.
				  Each analytical laboratory shall be housed in well lighted, sanitary, properly
				  vented quarters equipped with hot and cold running water, and toilet facilities
				  and shall contain ample space to process and examine the samples commensurate
				  with the total workload. Furthermore, said analytical laboratories shall:
1. be in distinct and separate locations from
				  living quarters unless provisions exist for separate entrances and plumbing
				  fixtures;
2. have ample workbench
				  space, be well lighted and have sufficient water, gas, suction, electrical
				  outlets and sinks;
3. have adequate
				  and proper storage space for all chemicals including explosive, flammable,
				  corrosive and caustic materials;
4.
				  have flooring composed of non-porous material in laboratory areas where acids,
				  caustics, and solvents are used;
5.
				  have adequate temperature and humidity controls as may be required for proper
				  performance of tests and operation of instruments affected by environmental
				  conditions;
6. have adequate
				  electrical supply; and
7. have
				  adequate refrigeration for samples, standards, and reagents used in testing
a.  food for consumption may not be stored in
				  refrigerators containing laboratory materials.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.9 - Safety && Security

Current through June 14, 2024
A. Adequate safety
				  and security precautions shall be established and maintained. Safety
				  instructions shall be present in a laboratory safety manual for the protection
				  of personnel from exposure to physical, chemical and biological hazards in
				  laboratories. The laboratory safety manual shall include applicable procedures
				  for the protection of employees and visitors.
B. Personnel shall be given a safety
				  orientation reviewing policies and procedures in the safety manual.
C. Samples, standards, reagents, solvents,
				  acids, chemicals and data must be kept in restricted access areas.
D. The laboratory must supervise visitors,
				  repairmen, and maintenance workers in restricted areas.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.10 - Waste Disposal

Current through June 14, 2024
A. The laboratory
				  must manage medical waste pursuant to the Medical Waste Regulations (250-RICR-
				  140-15-1).
B. The laboratory must
				  manage hazardous waste pursuant to the Rules and Regulations for Hazardous
				  Waste Management (250-RICR- 140-10-1).
C. Wastes, which are not classified as
				  medical waste or hazardous waste or which are not otherwise regulated by law or
				  rule, may be disposed in dumpsters or load packers provided the following
				  precautions are maintained:
1. Dumpsters
				  shall be tightly covered, leak proof, inaccessible to rodents and animals, and
				  placed on concrete slabs preferably graded to a drain. Water supply shall be
				  available within easy accessibility for washing down of the area. In addition,
				  the pickup schedule shall be maintained with more frequent pickups when
				  required. The dumping site of waste materials must be in sanitary landfills
				  approved by the Department of Environmental Management; and
2. Load packers must conform to the same
				  restrictions required for dumpsters and shall be high enough off the ground to
				  facilitate the cleaning of the underneath areas of the stationary equipment and
				  the loading section shall be construed and maintained to prevent rubbish from
				  blowing away.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.11 - Variance Procedure

Current through June 14, 2024
A. The Department
				  may grant a variance either upon its own motion or upon request of the
				  applicant from the provisions of any rule or regulation in specific instances
				  where it is found that literal enforcement of such provisions will result in
				  unnecessary hardship to the applicant and such variance will not be contrary to
				  federal regulations, the public interest, public health, or health and safety
				  of individuals.
B. A request for
				  variance shall be made in writing, setting forth in detail the basis of the
				  request.
C. Upon filing of such
				  request with the Department and within a reasonable time thereafter, the
				  Department shall notify the applicant by certified mail of its approval, or in
				  case of a denial, a hearing date, time, and place may be scheduled if the
				  applicant appeals the decision.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.12 - Violations

Current through June 14, 2024
In addition to revocation or suspension of certificates
					 granted, any person who violates the statutory or regulatory provisions of this
					 Part shall be subject to the sanctions of R.I. Gen. Laws §
										23-16.2-13.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 5 - Certifying Analytical Laboratories › Section 216-RICR-60-05-5.13 - Rules Governing Practices && Procedures

Current through June 14, 2024
All hearings and reviews required under the provision of
					 this Part will be held in accordance with Practices and Procedures Before the
					 Rhode Island Department of Health (Part 10-05-4 of this Title) and Access to
					 Public Records (Part 10-05-1 of this Title).
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.1 - Authority

Current through June 14, 2024
These regulations are established pursuant to R.I. Gen.
					 Laws §§
										21-28.6-12(f)(10) 
					 and  21-28.6-16(f)  for
					 the purpose of establishing the minimum standards for licensing analytical
					 laboratories to collect, sample, and analyze cannabis products cultivated
					 and/or manufactured by registered compassion centers and licensed cultivators.
					 This is required to ensure the qualifications and competence of personnel and
					 to ensure the adequacy of equipment, facilities, procedures, and quality
					 systems required to characterize cannabinoid identity and content profiles, and
					 test samples of finished cannabis products for biological and chemical
					 contaminants. These regulations also establish the form and content of initial
					 and renewal applications for licensing.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.2 - Limitations

Current through June 14, 2024
The scope of these regulations is limited to authorized
					 activities under the Edward O. Hawkins and Thomas C. Slater Medical Marijuana
					 Act [R.I. Gen. Laws Chapter
					 21-28.6] ("Medical Marijuana Act")
					 and does not extend to any acquisition, possession, cultivation, manufacture,
					 delivery, transfer, transportation, or sale for other purposes. See R.I. Gen.
					 Laws §§
										21-28.6-3(15)  and
					  21-28.6-2(5).
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.3 - Incorporated Materials

Current through June 14, 2024
A. These
				  Regulations hereby adopt and incorporate Codex Alimentarius Commission,
				  "General Guidelines on Sampling" CAC/GL 50-2004 not including any further
				  editions or amendments thereof and only to the extent that the provisions
				  therein are not inconsistent with these Regulations.
B. These Regulations hereby adopt and
				  incorporate Association of American Feed Control Officials (AAFCO) "Guidance on
				  Obtaining Defensible Samples" or "GOODS" (2015) by reference, not including any
				  further editions or amendments thereof and only to the extent that the
				  provisions therein are not inconsistent with these Regulations.
C. These Regulations hereby adopt and
				  incorporate USDA Establishment of a Domestic Hemp Production Program  7 C.F.R.
				  Part 990  Subpart B - State and Tribal Hemp Production Plans, issued January 19,
				  2021 by reference, not including any further editions or amendments thereof and
				  only to the extent that the provisions therein are not inconsistent with these
				  Regulations.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.5 - Cannabis Tracking System

Current through June 14, 2024
A. Upon direction
				  by RIDOH, each analytical laboratory licensed under the provisions of these
				  regulations shall be required to utilize the state approved Cannabis Tracking
				  System to document and monitor compliance with the Medical Marijuana Act, and
				  these regulations and may be required to pay costs associated with use of the
				  Cannabis Tracking System which may be assessed on an annual, monthly, per use,
				  or per volume basis and payable to the state or to its approved
				  vendor.
B. In accordance with the
				  Uniform Electronic Transactions Act (UETA), R.I. Gen. Laws Chapter
				  42-127.1 RIDOH may determine
				  whether, and the extent to which, it will accept electronic records, documents,
				  notifications, and signatures from other persons or entities where these
				  regulations refer to written records, documents, notifications, and
				  signatures.
C. Wherever these
				  regulations have recordkeeping and reporting requirements, such data and
				  information must be recorded and reported through the Cannabis Tracking System
				  wherever said System is configured for such recording and reporting, in
				  addition to any other means/mechanisms of recording and reporting required by
				  RIDOH. RIDOH will provide further guidance on use of the Cannabis Tracking
				  System, when it is mandatory or encouraged to be used as a substitute for or
				  supplement to any other specifically mentioned means/mechanisms in these
				  regulations, and timing for system utilization.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.6 - Application and Licensing Process Details

Current through June 14, 2024
The analytical laboratory must fulfill the following
					 general requirements to apply for and renew a license for sampling and testing
					 cannabis. Unless otherwise specified, all requirements of these regulations
					 apply to the analytical laboratory.
6.6.1
General Requirements
A. Submit application for a license on forms
				  provided by the RIDOH for initial licensing and for license renewal.
B. Include information as the RIDOH requires
				  which may include affirmative evidence of ability to comply with the provisions
				  of the Medical Marijuana Act and these Regulations.
C. RIDOH will evaluate applicants based upon
				  the information provided by applicants on the application forms/submissions and
				  otherwise obtained during the application process.
D. Only applications that RIDOH has
				  determined to be complete shall be eligible for review. An applicant who
				  submits an incomplete application shall receive written notification from RIDOH
				  regarding the specific deficiencies and shall be allowed to resubmit additional
				  material to address these deficiencies within thirty (30) days.
E. Upon notification of an approval of an
				  application from RIDOH, the approved applicant must take reasonable and
				  documented efforts to complete the prerequisites to the issuance of a license.
				  If such efforts take longer than nine (9) months, the approved applicant must
				  show good cause to RIDOH why additional time should be granted and the
				  application approval should not be rescinded.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.8 - Inspections

Current through June 14, 2024
A. After the analytical laboratory license is
				  issued, the analytical laboratory shall notify RIDOH when it commences
				  operations. RIDOH may conduct a post-licensing inspection upon this
				  commencement of operations, including but not limited to inspection for
				  compliance of cannabis product sampling, chain of custody and testing
				  requirements set forth in these regulations.
B. The Director or authorized agent(s) shall
				  at all times have authority to enter upon all parts of the premises on which
				  any cannabis plant or product analysis is conducted and of the premises
				  appurtenant thereto, as well as the premises on which finished cannabis plant
				  or products samples are collected by employees of the analytical laboratory
				  testing. The purpose of these visits will be to observe and evaluate the sample
				  collection and chain of custody procedures and/or for determining compliance
				  with the provisions of the Medical Marijuana Act and these
				  Regulations.
C. Each cannabis
				  analytical laboratory shall be provided a written report by the Department of
				  all deficiencies recorded because of an inspection or investigation within
				  sixty (60) days of such inspection or investigation.
D. The cannabis analytical laboratory shall
				  provide a plan of corrective action, including expected completion dates for
				  all deficiencies listed on such report within thirty (30) days of
				  receipt.
E. At the discretion of
				  the Director, a follow-up inspection may be conducted to assure that all
				  deficiencies have been corrected.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.9 - Laboratory Governing Body, Management, and Personnel

Current through June 14, 2024
6.9.1
Governing Body
A. Each laboratory must have a governing body
				  or equivalent legal authority ultimately responsible for:
1. The management and control of the
				  operation;
2. The assurance of the
				  quality of services;
3. The
				  compliance with all state and local laws and regulations; and
4. Compliance with other relevant health and
				  safety requirements, including these Regulations.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.10 - Record Keeping

Current through June 14, 2024
A. Each laboratory
				  must maintain appropriate records and reports, which must be available for
				  inspection by authorized representatives of the RIDOH. Create, control, and
				  maintain records of raw data, chain-of-custody records, calculations, quality
				  control data, and other essential documentation. Complete all records with
				  signatures, units of measurement, and documentation sufficient for verification
				  of results. Retain all records in such a manner as to permit prompt retrieval.
				  Records must include:
1. Records of the
				  operation and maintenance of all laboratory equipment;
2. Records of all sample collection,
				  preparation, and analysis;
3.
				  Records of control values, standard values, calibration curves and calculations
				  of standard deviations; and
4.
				  Reports of proficiency testing programs and of such other records as may be
				  deemed necessary.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.12 - Cannabis Proficiency Testing (PT) and Demonstration of Capability

Current through June 14, 2024
A. The quality assurance plan must include
				  standard procedure for determining the capability of its analysts before they
				  can begin conducting quantitative analysis of cannabis products.
B. RIDOH must be notified when significant
				  changes are made to the standard analytical procedure such as changes to
				  extraction technique or the instrumentation used.
C. Each analyst is required to perform
				  initial demonstration of capability prior to implementing routine
				  analyses.
D. Each laboratory must
				  participate in a proficiency testing program approved by RIDOH for each analyte
				  (or group of analytes), matrix and method for which the laboratory is certified
				  or is requesting certification. Proficiency testing samples must be procured
				  from a proficiency testing provider approved by RIDOH. RIDOH may require that
				  the proficiency testing program include "round robin" proficiency testing
				  whereby samples from the same batch are tested by more than one licensed
				  analytical laboratory for comparison of results.
E. If proficiency test samples are not
				  commercially available, analytical laboratories must submit a plan to define
				  and develop in-house quality control samples it will use to demonstrate its
				  proficiency for each analyte, matrix, and method of analysis. The plan must
				  include:
1. The source of the
				  sample,
2. The matrix
				  type,
3. Preparation
				  procedure,
4. Testing
				  procedure,
5. Target analytes in
				  the sample,
6. How the analyte
				  concentration was determined,
7.
				  Control limits and how they were determined, and
8. Shelf life and expiration
				  testing.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.13 - Procedure Manual

Current through June 14, 2024
A. Each analytical
				  laboratory must have available, always, in the immediate working areas of
				  personnel engaged in conducting analytical laboratory sample collection, sample
				  accessioning and testing, a procedure manual which includes a detailed
				  compilation of all automated and manual methods and procedures for sample
				  collection, chain-of-custody, and analytical testing which is performed by the
				  laboratory and for which it is licensed. Such manuals must:
1. Be written in a uniformly consistent
				  format;
2. Specify the approved
				  method employed;
3. Describe the
				  quality control activities pertinent to the method;
4. Contain information concerning preparation
				  and storage of media, reagents, control and calibration procedures and
				  pertinent literature references;
5.
				  Describe the laboratory's technical procedures for the collection,
				  transporting, processing and examination of samples;
6. For tests, which are normally performed on
				  automated test equipment, provide for alternate methods or for storage of test
				  samples, in the event the automated equipment becomes inoperable;
				  and,
7. Be approved, signed, and
				  dated by the current laboratory supervisor/director and the QA Officer. Changes
				  in procedures must be approved, signed, and dated by the current
				  supervisor/director and QA Officer.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.14 - Facility, Equipment and Supplies

Current through June 14, 2024
6.14.1
Facility
A. Each analytical
				  laboratory must:
1. Be housed in well lighted,
				  sanitary, vented quarters equipped with hot and cold running water, and toilet
				  facilities and contain ample space to process and examine the samples
				  commensurate with the total workload;
2. Be in distinct and separate locations from
				  living quarters unless provisions exist for separate entrances, and plumbing
				  fixtures;
3. Have ample workbench
				  space, have sufficient water, gas, suction, electrical outlets, and
				  sinks;
4. Have adequate and proper
				  storage space for all chemicals including explosive, flammable, corrosive, and
				  caustic materials;
5. Have flooring
				  composed of non-porous material in laboratory areas where acids, caustics, and
				  solvents are used;
6. Have adequate
				  temperature and humidity controls as may be required for proper performance of
				  tests and operation of instruments affected by environmental
				  conditions;
7. Have adequate
				  electrical supply; and
8. Have
				  adequate refrigeration for samples, standards, and reagents used in
				  testing.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.15 - Safety and Security

Current through June 14, 2024
A. The laboratory
				  must establish and maintain adequate safety and security precautions.
B. Safety instructions must be present in a
				  laboratory safety manual for the protection of personnel from physical,
				  chemical, and biological hazards. The laboratory safety manual must include
				  applicable programs for the protection of employees as outlined in the Code of
				  Federal Regulations (  29 C.F.R. Part 1910 ), including, but not limited to, the
				  Occupational Safety and Health Administration standards for hazard
				  communication, and occupational exposure to hazardous chemicals in
				  laboratories.
C. Laboratory
				  management and personnel must be given a safety orientation and annually review
				  policies and procedures in the safety manual including the proper use of
				  security measures and procedures that have been adopted specific to responding
				  to an emergency, including robbery, violence, or accident.
D. The laboratory must keep samples,
				  standards, reagents, solvents, acids, chemicals, and data in restricted access
				  areas.
E. The laboratory must have
				  visitors, repairmen, and maintenance workers sign in upon entry and supervise
				  them in restricted areas.
F.
				  Implementation of the minimum security requirements stated in the rules and
				  regulations related to the Medical Marijuana Program Administered by the
				  Department of Business Regulation (§§230-RICR-80-05-1.4(G)(2) through
				  (7)) shall be deemed by RIDOH to be
				  substantially compliant with the security requirements of these
				  Regulations.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.16 - Waste Disposal

Current through June 14, 2024
A. Cannabis Waste
				  and Destruction of Usable Cannabis Excluding Hemp
1. Cannabis and cannabis product waste
				  (including all liquid, chemical, hazardous, pesticide, manufacturing solvent
				  and chemical waste containing any traces of cannabis) must be stored, secured,
				  and managed in accordance with all applicable state, and local statutes,
				  regulations, ordinances, or other legal requirements.
2. Prior to disposal, cannabis and cannabis
				  product waste must be made unusable and any cannabis plant material made
				  indistinguishable from other plant material. This may be accomplished by
				  grinding and incorporating the cannabis plant waste with other non-consumable
				  solid waste or other ground materials so the resulting mixture is at least
				  fifty percent (50%) non-cannabis waste by volume. Other methods to render
				  cannabis waste unusable must be approved by DBR before implementing.
Cannabis waste rendered unusable following an approved
					 method may be delivered to a licensed solid waste disposal facility in Rhode
					 Island for final disposition or disposed of in an alternative manner approved
					 by DBR.
3. Destruction of
				  cannabis and cannabis materials other than waste generated in the regular
				  course of processing and/or manufacturing (such as destruction of whole plants,
				  wet, or usable cannabis that are found to be more than statutory possession
				  limits or destruction of a contaminated batch of cannabis product) must be in a
				  manner acceptable to DBR, which may include consultation with law
				  enforcement.
4. Destruction of
				  cannabis and cannabis materials upon revocation or abandonment of the license
				  must be specifically governed by DBR order or agreement and/or coordinated
				  efforts with law enforcement.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.19 - Sample Accessioning

Current through June 14, 2024
A. Analytical
				  laboratories receiving samples from the sample collector must complete the COC
				  forms to record accessioning and internal tracking of samples including the
				  following information:
1. The laboratory
				  internal tracking number or other identification;
2. Printed name and signature of the person
				  receiving the samples;
3. Date and
				  time of sample receipt;
4.
				  Condition of sample upon receipt;
5. Type of tests requested;
6. The name, address, and license number of
				  analytical laboratory to which sample(s) are forwarded for procedures not
				  performed on the premises each of which must be numbered or otherwise
				  appropriately identified;
7. Sample
				  tracking through each stage of storage, analysis, and disposal;
8. Date laboratory tests are
				  performed;
9. The analytical
				  laboratory test results;
10. Date
				  of reporting; and,
11. Sample test
				  reports.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.20 - Sample Preparation

Current through June 14, 2024
A. Analytical
				  laboratories must have a designated area of the facility dedicated to preparing
				  cannabis product samples for analysis. Sample preparation areas must be
				  equipped with the supplies and equipment to properly handle samples during
				  preparation including:
1. Disposable
				  gloves;
2. Decontaminated tool(s)
				  such as disposable pipettes and plastic or stainless steel spatulas, knives,
				  and sampling spears;
3.
				  Decontaminated stainless steel bowls and implements to homogenize the product
				  by stirring, chopping, or grinding;
4. Clean, decontaminated surfaces for sample
				  processing;
5. Decontaminated
				  sample containers appropriate for the analyses required;
6. Container labels and pens with indelible
				  ink; and,
7. Supplies to thoroughly
				  clean, decontaminate, and dry sample preparation equipment between
				  samples.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.21 - Sample Analysis

Current through June 14, 2024
A. General
				  Requirements
1. All cannabis product samples
				  described in these regulations must be analyzed by analytical laboratories
				  licensed by the RIDOH.
2. Use only
				  chemical standards manufactured by a provider acceptable to the Director to
				  prepare calibration and quality control standards. Analytical laboratories must
				  maintain standard preparation records and the certificates of analysis for all
				  chemical standards, reference materials and reagents for at least five (5)
				  years.
3. Licensed analytical
				  laboratories must demonstrate the ability to perform the quantitative
				  analytical methods approved by RIDOH, and to provide defensible documentation
				  and quality assurance.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.22 - Quality Control

Current through June 14, 2024
A. Prepare and
				  analyze samples in batches of up to twenty (20) samples that include a
				  laboratory reagent blank, a laboratory fortified blank, a sample duplicate, and
				  a laboratory fortified sample for chemical tests.
B. Initial Calibration
The analytical sequence must include initial and continuing
					 instrument calibrations performed per the approved method requirements. If the
					 approved method does not specify calibration requirements, then analytical
					 laboratories must at a minimum perform a three-point initial calibration
					 spanning a concentration range from below to above the maximum allowable
					 contaminant concentration. Analytical laboratories are required to achieve a
					 linear response for all cannabinoids, metals, pesticides and solvent analyses.
					 The initial calibration for each analyte must have a relative standard
					 deviation of fifteen percent (15%) or a correlation factor of
					 0.995.
C. Continuing
				  Calibration
If approved analytical methods do not specify calibration
					 requirements, the analytical sequence must include a continuing calibration
					 standard and continuing calibration instrument blank before and after every ten
					 samples (including quality control samples). The percent difference of the
					 continuing calibration response for all analytes must be equal to or less than
					 fifteen percent (15%) compared to the expected continuing calibration standard
					 response. Analytical laboratories must document the calibration performance and
					 quality control results for all analyses.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 60 - Laboratories and Medical Examiner › Subchapter 05 - State Laboratory › Part 6 - Licensing Analytical Laboratories for Sampling and Testing Cannabis › Section 216-RICR-60-05-6.23 - Test Reporting

Current through June 14, 2024
A. Analytical
				  laboratories must report all testing results including all information
				  necessary to determine product compliance to the Department of Business
				  Regulation Cannabis Tracking System and the cannabis producer including
				  registered compassion centers and licensed cultivators.
B. Include the following in the laboratory
				  data package: case narrative, chains-of-custody, and summary of analytical
				  results.
1. A case narrative written on
				  laboratory letterhead, must describe any sample receipt, preparation, or
				  analytical issues encountered as well as any method non-conformances or
				  exceedance of QA/QC criteria used by the laboratory. The narrative must
				  identify the preparation and analytical methods utilized by the laboratory. The
				  narrative must include a signed statement by an authorized laboratory
				  representative as to the accuracy, completeness, and compliance with the
				  methods of the results presented.
2. Chains-of-custody (COC) information or
				  other paperwork indicating requested analyses and documentation of sample
				  collection and receipt must be reported with the laboratory's
				  results.
3. Laboratory reports must
				  clearly identify the name, address, and license number of the laboratory (which
				  may be a subcontracted laboratory) that performed the test(s), and must include
				  the results and the date of the reporting.
4. Multipage reports must be
				  paginated.
5. Summary of analytical
				  results including sample identifier, methods performed, target compounds,
				  sample result or reporting limit, proper qualifier according to laboratory
				  standard procedures, units of measure, preparation date(s), where applicable,
				  and analysis date(s).
6. Analytical
				  results, which exceed the upper limit described in §§
											6.21(D)(2),
				   6.21(E)(3),  6.21(F)(1),  6.21(G)(2), and  6.21(H)(3)   of this Part must be
				  reported with a qualifier indicating the contaminant measured in the cannabis
				  product is above the allowable concentration.
7. The laboratory data package must include
				  sufficient data to evaluate the laboratory results, including a summary of
				  laboratory QA/QC results.
8.
				  Cannabis products, which are determined to be out of compliance may be
				  resampled for follow-up testing. A production batch may be retested once and
				  records of the original analysis must be retained.