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
Universal Citation: 216 RI Code of Rules 60 05 5.7
Current through September 18, 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.
5.7.2 Procedure Manual
A. Each
analytical laboratory shall have available, at all times, in the immediate
bench area of personnel engaged in conducting analytical laboratory testing, a
procedure manual which includes a detailed compilation of all automated and
manual methods and procedures for all analytical tests which are performed by
the laboratory and for which it is certified. Furthermore, such manuals shall:
1. Specify the approved method
employed;
2. Describe the quality
control activities pertinent to the method;
3. Contain information concerning preparation
and storage of media, reagents, control and calibration procedures and
pertinent literature references;
4.
Describe the laboratory's technical procedures for the collection, processing
and examination of samples;
5. For
those 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
6. 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.
7. Required methodologies for testing can be
found in EPA Manual for the Certification of Laboratories Analyzing Drinking
Water, Supplement 1 to the Fifth Edition of the Manual for the Certification of
Laboratories Analyzing Drinking Water, Standard Methods for the Examination of
Water and Wastewater, Methods for the Chemical Analysis of Water and Wastes
and, Methods for the Organic Chemical Analysis of Municipal and Industrial
Wastewater incorporated at §§
5.2(D) through
(H) of this Part.
5.7.3 Collection, Identification && Examination of Samples
A. Information that accompanies samples shall
be sufficiently detailed to permit identification and document chain of
custody.
B. The laboratory shall
not accept samples for examination unless there is sufficient documentation to
verify proper collection, preservation, and other conditions as prescribed in
the relevant methods, and to permit adherence to holding times.
C. The laboratory shall not accept samples
for examination without sufficient sample volume to perform the requested
analyses.
D. Each analytical
laboratory shall maintain a record indicating the daily accession of samples,
each of which shall be numbered or otherwise appropriately identified. The
records of samples shall contain no less than:
1. the laboratory number or other
identification,
2. the name of the
person or analytical laboratory that submitted the sample,
3. date of sample collection,
4. date of sample receipt,
5. condition of sample upon
receipt,
6. type of test requested
and performed,
7. the results and
date of laboratory tests and date of reporting, and
8. the name and address of laboratory to
which the sample(s) is forwarded for procedures not performed on the
premises.
5.7.4 Other Applicable Regulations
An analytical laboratory certified in the category of radiochemistry shall comply with the Rules and Regulations for the Control of Radiation and shall obtain, as applicable, the appropriate radioactive materials license from the Department.
5.7.5 Proficiency Testing
A. Each laboratory shall participate in a
proficiency testing program approved by the Department for each analyte (or
group of analytes) and method for which the laboratory is certified or is
requesting certification. Proficiency testing samples shall be procured from a
provider of proficiency test samples accredited by a Proficiency Testing
Provider Accreditor (PTPA) that meets the TNI requirements.
B. The laboratory shall analyze a PT sample
annually for each analyte and matrix by each method and receive an acceptable
evaluation from the PT provider for that analyte/method/matrix, with the
following exceptions:
1. laboratories
certified for environmental lead must maintain a proficient status according to
their respective accrediting agency;
2. laboratories must receive an acceptable
evaluation for at least eighty percent (80%) of the Regulated Volatile Organic
Compounds and eighty percent (80%) of Haloacetic Acids, in potable water, to
maintain certification for these analyte groups, (as defined in the reference
incorporated above at §
5.2(A) of
this Part); and,
3. laboratories
certified for potable and non-potable water-microbiology must correctly analyze
ninety percent (90%) of the samples in a shipment with no false negatives for
qualitative microbiology proficiency testing, and for quantitative microbiology
proficiency testing no more than one (1) of the target organisms in a sample
set containing three (3) or more samples may be incorrectly
quantified.
C.
Proficiency test results shall be submitted directly from the accredited
provider to the certification office by October 31 of each year. The Department
shall be designated as the recipient of the laboratory results before the
results are available to the laboratory.
D. Whenever a laboratory receives an
unacceptable evaluation for an analyte in a study, it shall determine the cause
for the failure, take corrective action, and participate in another PT study
for the failed analyte. Documentation of the investigation and corrective
action shall be maintained and a copy provided to the Department before the
next proficiency testing study.
E.
Failure to complete PT studies or failure to obtain an acceptable result in a
PT study as specified in § 5.7.5(D) of this Part shall result in loss of
certification for the analyte until two (2) consecutive PT studies resulting in
acceptable evaluations have been completed. There shall be an interval of at
least thirty (30) days between the two (2) studies.
F. All proficiency test samples shall be
analyzed in the same manner and frequency as a real environmental sample using
the same staff, procedures and equipment.
G. Laboratories shall not send a PT sample,
or a portion thereof, to another laboratory for any analysis for which it is
certified or seeks certification.
H. A laboratory shall not knowingly receive
any PT sample, or a portion thereof, from another laboratory for any analysis
for which the sending laboratory is certified or seeks certification.
I. Laboratory management or staff shall not
communicate with any individual at another laboratory concerning a PT sample or
attempt to obtain the assigned value from their PT provider.
J. All raw data obtained in analyzing PT
samples shall be retained and be available for review for a minimum of five (5)
years.
K. The use of supplemental
PT samples shall be allowed only if the PT provider certifies, in writing, that
PT samples meet the criteria specified by the EPA.
L. A laboratory not located in Rhode Island
shall follow the proficiency testing requirements of the state in which it is
located.
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
