216 R.I. Code R. 216-RICR-60-05-6.14

Current through December 26, 2024

Section 216-RICR-60-05-6.14 - Facility, Equipment and Supplies

6.14.1Facility

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.

6.14.2Equipment 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.

216 R.I. Code R. 216-RICR-60-05-6.14

Amended effective 12/7/2023