Current through Register Vol. 30, No. 38, September 20, 2024
A. A
person who has obtained laboratory certification under this Article shall
maintain a master file for each certification. The person shall update the
master file within 30 days of any change. The master file shall contain:
1. The most current letter of certification,
stating the period of validity;
2.
A quality assurance manual as described in subsection (B);
3. An organizational chart that indicates:
a. Each personnel position with
responsibility for the agricultural laboratory service; and
b. The reporting relationship of each
position identified in subsection (A)(3)(a), including every administrative,
operational, and quality control relationship;
4. The name and resume of the individual
assigned to each position identified in subsection (A)(3)(a);
5. Documentation of training for each staff
member who performs all or part of the agricultural laboratory
service;
6. Documentation of the
laboratory's competence and experience in the applicable test procedure for the
agricultural laboratory service;
7.
Reports of each sample result for the last three years and all data generated
during the testing. After three years, these records shall be maintained as
prescribed in subsection (D). With the approval of the Assistant Director, a
person may maintain records in electronic format;
8. Laboratory equipment lists, including:
a. Type and manufacturer;
b. Serial and model number;
c. Date of the last calibration, if
applicable; and
d. Maintenance
records;
9. Receiving
and shipping records of all samples and supplies relating to the
certification;
10. Quality control
documentation;
11. Documentation of
reference material, standards, and biological specimens as prescribed in
subsection (B)(5); and
12. All
correspondence relating to the certification and operation of the
program.
B. A person who
has obtained laboratory certification shall maintain a quality assurance
manual. The person shall update the manual within 30 days of any change, except
that any change to a testing procedure requires pre-approval from the Assistant
Director based on a request made at least 30 days before the proposed
implementation date. The manual shall contain:
1. A description of laboratory management and
the responsibilities of personnel related to the certification that includes:
a. The legal name, address, and telephone
number of the main office or parent company;
b. The name, location of the laboratory, and
telephone number, if different from subsection (B)(1)(a);
c. The education, skill, and experience
required of an individual in a position included in the organizational chart
prescribed in subsection (A)(3); and
d. A description of the method used to train
each person in a position included in the organizational chart prescribed in
subsection (A)(3);
2.
Procedures for receiving and handling samples, including:
a. Transporting samples to the laboratory in
a manner that protects the integrity of the sample;
b. Performing a visual examination upon
receipt for evidence of shipping damage;
c. Recording date and time of sample receipt,
carrier name, and method of shipment;
d. Recording sample weight, temperature, or
other physical parameters, as applicable;
e. Completing chain of custody documentation
for receipt, as applicable;
f.
Identifying a sample with a unique identification number;
g. Storing a sample before and after testing;
and
h. Disposing of samples after
completion of testing, including holding time;
3. Procedures for purchasing, receiving and
storing reagents and laboratory consumable materials that affect the quality of
tests;
4. A written standard
operating procedure for each test as prescribed in
R3-5-106. A
standard operating procedure for a test shall contain, as applicable:
a. An identification of the standard
operating procedure, including the title, revision number, effective date, and
authorizing signature;
b. The
purpose of the procedure, including a description of the expected
outcome;
c. The scope of the
procedure, including a description of the type of samples and test parameters
for which the procedure is applicable;
d. A list of reagents, apparatus, and
equipment used, including technical performance requirements;
e. A list of necessary reference standards or
reference materials;
f. A
description of acceptable environmental conditions;
g. A sequential listing, in detail, of the
steps and operations of the procedure;
h. An identification of any hazardous
situation or operation;
i. A list
of safety measures specific to the test procedure;
j. A list of precautions designed to prevent
damage or contamination to a sample or testing equipment;
k. Any quality control measures that will be
used to determine acceptability of a test result, including acceptance
criteria;
l. A list of data to be
recorded and the method for reporting the test result; and
m. The procedure's uncertainty or the method
to be used for reporting uncertainty;
5. Procedures for documenting applicable
reference material, standards, and biological specimens that provide:
a. Traceability of each chemical standard of
measurement to a primary standard;
b. Verified and traceable biological
specimens; and
c. Origin and
traceability of reference material;
6. A description of an equipment maintenance
program that includes:
a. Each manufacturer's
recommendations for the set-up and normal operation of each piece of
equipment;
b. A separate
maintenance schedule for each piece of equipment, and a procedure for recording
the date maintenance is performed and the date of any damage, malfunction,
modification, or repair of the equipment; and
c. Quality control procedures for determining
equipment performance; and
7. Procedures for quality control activity,
including:
a. Monitoring
temperature-controlled spaces;
b.
Certifying that each thermometer, analytical balance, and biological hood meets
federal or nationally-recognized standards, as applicable;
c. Calibrating glassware and volumetric
equipment, as applicable; and
d.
Validating the quality of reagents and laboratory consumable material, as
applicable.
C. A person who has obtained laboratory
certification shall ensure the accurate calibration of testing
equipment.
D. A person who has
obtained laboratory certification shall maintain records required under this
Article for five years, except pesticide residue sample results and data, which
shall be maintained for seven years;
E. A person who has obtained laboratory
certification shall maintain a facility and conduct operations in compliance
with the standards established by the Occupational Safety and Health
Administration and any other applicable federal, state, or local building,
sanitary, safety, electrical, and fire code for the area in which the
laboratory is located.
F. A person
who has obtained laboratory certification shall dispose of hazardous waste
cataloged in the Identification and Listing of Hazardous Waste, 40 CFR 261,
July 1, 2003 edition, as prescribed in the Standards Applicable to Generators
of Hazardous Waste, 40 CFR 262, July 1, 2003 edition. This material is
incorporated by reference, does not include any later amendments or editions,
and is on file with the Department.
