Section R3-5-105. Laboratory Requirements

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 administra- tive, 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 expe- rience 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 subsec- tion (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 sup- plies relating to the certification;

10.     Quality control documentation;

11.     Documentation of reference material, standards, and bio- logical specimens as prescribed in subsection (B)(5); and

12.     All correspondence relating to the certification and opera- tion of the program.

B.       A person who has obtained laboratory certification shall main- tain 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 respon- sibilities 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 organiza- tional chart prescribed in subsection (A)(3); and

d.        A description of the method used to train each per- son in a position included in the organizational chart prescribed in subsection (A)(3);

2.        Procedures for receiving and handling samples, includ- ing:

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 qual- ity 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 proce- dure, including the title, revision number, effective date, and authorizing signature;

b.        The purpose of the procedure, including a descrip- tion 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 condi- tions;

g.        A sequential listing, in detail, of the steps and opera- tions of the procedure;

h.        An identification of any hazardous situation or oper- ation;

i.         A list of safety measures specific to the test proce- dure;

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 mate- rial, standards, and biological specimens that provide:

a.        Traceability of each chemical standard of measure- ment 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 dam-

age,  malfunction,  modification,  or  repair  of  the equipment; and

c.        Quality control procedures for determining equip- ment performance; and

7.        Procedures for quality control activity, including:

a.        Monitoring temperature-controlled spaces;

b.        Certifying that each thermometer, analytical bal- ance, and biological hood meets federal or nation- ally-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 main- tain records required under this Article for five years, except pesticide residue sample results and data, which shall be main- tained for seven years;

E.       A person who has obtained laboratory certification shall main- tain 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 dis- pose 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 Depart- ment.

Historical Note

Adopted effective July 25, 1985 (Supp. 85-4). Former Section R3-1-205 renumbered without change as Section R3-5-105 (Supp. 89-1). Section R3-5-105 renumbered from R3-1-705 (Supp. 91-4). Section repealed, new Sec- tion adopted by final rulemaking at 5 A.A.R. 573, effec- tive February 4, 1999 (Supp. 99-1). Amended by final

rulemaking at 10 A.A.R. 3959, effective November 13,

2004 (Supp. 04-3).