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-60-05-5.7 - Quality Assurance and Quality Control Programs

Current through June 14, 2024
5.7.1
General Requirements
A. Each analytical laboratory shall have
				  clearly established internal and external quality controls to ensure high
				  standards of performance and reliability of test results. These quality
				  controls shall consider such factors as preventative maintenance, periodic
				  inspection, testing for proper validation of methods, evaluation of reagents
				  and volumetric equipment, surveillance of results, remedial action taken to
				  correct deficiencies and quality control failures and such other equivalent
				  factors as required in this Part and as may be deemed necessary.
B. The laboratory shall perform all analyses
				  which will be used for compliance with state or federal regulations, using the
				  prescribed methods incorporated above at §§
											5.2(A) through
				  (H)   of this Part.
C. The laboratory's quality assurance plan
				  shall be accessible to all personnel in the laboratory. It shall include, but
				  not be limited to:
1. sampling procedures (if
				  performed by the laboratory);
2.
				  laboratory sample handling procedures;
3. instrument calibration
				  procedures;
4. a list of detailed
				  analytical procedures or analytical references;
5. data reduction, validation, and reporting
				  procedures including non-compliance action plan;
6. types and frequency of internal audit
				  samples (quality control samples) and external audit samples (proficiency
				  testing samples);
7. internal audit
				  procedures and frequency;
8.
				  preventative maintenance procedures and schedules;
9. procedures for determining accuracy and
				  precision and method detection limits of all analytes and specified
				  frequency;
10. control limits and
				  corrective action policies;
11.
				  laboratory organization, staff, and responsibilities; and
12. procedures for laboratory and managerial
				  data review.
D. The
				  method detection limit (MDL) shall be determined prior to placing a new method
				  in service and annually thereafter for each analyte per  40 C.F.R. §
												136 Appendix B incorporated above at §
											5.2(A)   of
				  this Part, or other such MDL guidance as deemed appropriate by the Department.
1. Method Detection Limits determined by the
				  laboratory for analytes in the potable water category must meet the detection
				  limit criteria specified in
				   40 C.F.R. §§
													141.23 and  24  incorporated above
				  at §
												5.2(A)   of
				  this Part. If the laboratory cannot meet said criteria for an analyte, a
				  request for a variance must be submitted pursuant to §
												5.11   of this Part.
E. The laboratory shall follow the
				  quality control requirements specified in "Standards Methods for the
				  Examination of Water and Wastewater" incorporated above at §
											5.2(F)   of
				  this Part.
F. The laboratory shall
				  follow all applicable quality control activities described in the "EPA Manual
				  for the Certification of Laboratories Analyzing Drinking Water" incorporated
				  above at §
											5.2(D)   of
				  this Part. This requirement applies to pertinent non-potable water testing as
				  well.