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
Universal Citation: 216 RI Code of Rules 60 05 6.14
Current through September 18, 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.
6.14.2 Equipment and Supplies
A. The laboratory must possess suitable
equipment required for licensing that must meet the requirements of the
methods. All instruments must be physically located on site.
B. The laboratory must have sufficient
glassware and plastic labware necessary for the analyses. Glassware must be
borosilicate glass or other corrosion-resistant glass. It must be free of
cracks and chips. Markings and etchings must be legible. Volumetric flasks,
pipettes, and other glassware used for volumetric analysis must be class
"A."
C. The laboratory must have
sufficient facilities to wash and sterilize glassware, labware, and other
containers used in the analysis.
D.
All precision equipment and instruments (e.g., pipettors, pH meters,
conductivity meters) must be calibrated and checked for accuracy at regular
intervals as required by the method and the laboratory's quality assurance
policies. Documentation of calibration and accuracy checks must be maintained.
Records of service by a qualified instrument service organization must be
maintained.
E. Analytical balance
range and sensitivity must be appropriate for the application for which it is
used. Balances must be kept clean and free of corrosion and spillage and must
be checked daily with weights meeting ASTM Type I, Class 1 or 2 specifications
with values that bracket the laboratory's weighing needs. Records must be
maintained that include acceptance criteria for the checks. ASTM weights must
be recalibrated every five (5) years or immediately if nicked or corroded.
Non-reference weights may be used but must be calibrated every six (6) months
against ASTM type 1, 2 or 3 weights.
F. All balances must be calibrated annually
by a professional balance service. Certificates of calibration must be
maintained at the laboratory.
G.
Laboratories must arrange with Department of Labor and Training Office of
Occupational Safety (DLTOS) to have balances or scales used in the sample
collection process certified and sealed in accordance with R.I. Gen. Laws Title
47.
H. All incubators,
refrigerators, ovens, autoclave or sterilizers and water baths must contain
calibrated thermometers. The laboratory must maintain copies of the
certificates of calibration for each thermometer. Thermometer range and
graduation increments must be appropriate for the application for which it is
used. Glass thermometers must be checked for accuracy annually, and other types
of thermometers quarterly, by comparing with a NIST traceable thermometer at
the temperatures of interest. Thermometers must be tagged with the date of
accuracy check and the correction factor (may be zero (0)). There must be no
separation in the liquid column of glass thermometers.
I. Use analytical reagent grade chemicals
unless otherwise allowed or specified by the analytical method;
J. Date bottles of dehydrated microbiology
media when received and opened. Do not use media beyond the manufacturer' s
expiration date or within one (1) year from opening, whichever is sooner.
Discard immediately if caked or otherwise deteriorated. Prepared, or
prepackaged media are permitted.
K.
Use plastic labware for microbiology that is clear and non-toxic.
L. Reagent water for chemical analyses and
for general use must be distilled or deionized and have a resistivity value
greater than 0.5 megaohms/cm at twenty-five degrees Celsius (25° C).
Quality checks must be made according to specified analytical method
requirements, but at least monthly, with a conductivity meter. All such quality
checks must be recorded.
M. For
microbiological analyses, reagent water must meet all the following criteria:
PARAMETER |
LIMITS |
FREQUENCY |
resistivity |
> 0.5 megaohms/cm |
monthly |
Pb, Cd, Cr, Cu, Ni, Zn |
< 0.05 mg/L per contaminant and < 0.1 mg/L total |
annually |
total chlorine residual |
none detectable |
monthly |
Heterotrophic plate count |
< 500/mL |
monthly |
bacteriological quality of reagent water. |
ratio of growth rate: 0.8 to 3.0 (see Standard Methods, Section 9020B. This test is not required if laboratories use water that meets the criteria for Types I and II water as defined in Standard Methods Section 1080). |
annually |
N.
Label all reagents and solutions to indicate identity, concentration, storage
requirements, expiration dates and any other pertinent information.
O. Date all reagents and solutions when
received and opened. Do not use materials beyond their expiration
dates.
P. All laboratory prepared
reagents and solutions must be labeled with preparation and expiration dates.
No laboratory prepared materials shall be used beyond their expiration
dates.
Disclaimer: These regulations may not be the most recent version. Rhode Island may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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