N.J. Admin. Code § 7:18-7.7 - Laboratory quality control and recordkeeping

(a) A laboratory performing acute toxicity testing shall develop and implement a quality control program. The laboratory shall not perform acute toxicity testing without having such a program. The laboratory shall have a written description of its program on file and be able to produce a copy during an on-site inspection. The written description shall include all methods manuals used for culturing test organisms, and all testing protocols used by the laboratory. The quality control program description, or standard operating procedures (SOP) manual, shall be specific to the operations of the laboratory and not a generalized document.

(b) The laboratory shall make records of all analytical control tests and quality control checks on equipment and materials. The laboratory shall maintain the records for at least five years. The laboratory shall file and maintain data and other records in an accessible location on the laboratory's premises for one year after the date of analysis so that reviews can be conducted during on-site audits.

(c) If the laboratory discovers an error in the analysis of a regulatory sample, and the error may affect the validity of the reported analytical result, the environmental laboratory manager shall report the error to the regulatory program for which the analysis was conducted, and to the client. The laboratory shall make this notification within 72 hours after discovery of the error.

(d) Laboratories performing acute toxicity testing shall comply with the following requirements when performing quality control checks of laboratory media, equipment, and supplies:

1. Operate each pH meter in accordance with 7:18-3.3(a)3. Rinse the probe with laboratory pure water immediately after each use period. Label commercial buffer solutions with the date of receipt and the date of initial use;

2. Operate top loader or pan balances in accordance with 7:18-3.3(a)2;

3. Verify all temperature measuring devices using the procedures listed in 7:18-3.3(a)5;

4. The temperature of air or water-jacketed incubators, aluminum block incubators, water baths, and incubator rooms shall be recorded either continuously or daily from in-place thermometers immersed in liquid and placed on at least one of the shelves in use. Keep the records in a log book, signed and dated by the analyst;

5. Record date, time, pressure and temperature of an autoclave either continuously, or individually during each sterilization cycle. Keep the records in a log book, signed and dated by the analyst;

6. The time and temperature of hot air ovens shall be measured with a thermometer either continuously or individually during each cycle, with the bulb of the thermometer placed in sand. Record the date, time and temperature of each cycle. Keep the records in a log book, signed and dated by the analyst;

7. Monitor the temperature of each refrigerator in accordance with the procedures listed in 7:18-3.3(a)7;

8. Label all reagents and solutions to indicate identity and, when applicable, titer, strength or concentration, manufacturer's recommended storage requirements, preparation and expiration date, and other information pertinent to identification. Do not use materials of substandard reactivity or deteriorated materials. Discard all outdated material immediately;

9. At least annually, check conductivity and salinity meters equipped with conductivity cells having platinum electrodes. Perform the check over the range of interest using at least five concentrations of a standard potassium chloride solution. Check conductivity cells not having platinum electrodes against a conductivity meter equipped with platinum electrodes. Perform this check annually and record the raw data, cell constant, and results in a log book, signed and dated by the analyst; and

10. Check dissolved oxygen meters weekly, using the Winkler method. Record the results in a log book signed and dated by the analyst.

(e) Only the laboratory manager, supervisor or quality assurance officer is authorized to make changes in laboratory procedures. Changes are effective only if:

1. The change is made by the manager, supervisor or quality assurance officer of the laboratory;

2. The manager, supervisor or quality assurance officer makes the change in writing, signed and dated by the manager, supervisor or quality assurance officer, and includes the change in the laboratory's SOP manual.

(f) A laboratory shall not perform acute toxicity tests unless it keeps current laboratory SOP and reference manuals in the immediate bench area of laboratory personnel engaged in examining samples and performing toxicity testing and other related procedures. The laboratory may use textbooks to supplement the manuals, but shall not replace the manuals with the textbooks. The manuals shall include information relating to:

1. The analytical methods to be used, properly designated and dated to reflect the most recent supervisory reviews; and

2. Any applicable regulations.

(g) A laboratory conducting a flow-through toxicity test shall check the temperature in the exposure chambers, the flow rate through the exposure chambers, and the maintenance of effluent concentrations. The laboratory shall conduct these checks when the test is initiated, at least once every 24 hours for the duration of the test, and upon completion of the test. The laboratory shall document these measurements, and any resulting adjustments to the flow-through dilutor system, in the toxicity test report.

(h) A laboratory performing an acute toxicity test shall establish an acute toxicity test precision requirement that the 95 percent confidence interval be within +/-30 percent of the estimated or incipient EC[50] or LC[50] value.

(i) A laboratory performing acute toxicity tests shall keep records and report data in accordance with the requirements of (i)1 and 2 below. The records to be retained include raw data records, quality control data records, chain-of-custody forms, laboratory reports, and the information required under (i)2 below.

1. The laboratory shall retain each record for at least five years after the date of the analysis. The laboratory shall file and maintain data and other records in an accessible location on the laboratory's premises for one year after the date of analysis so that reviews can be conducted during on-site audits.

2. The laboratory shall record the following information as part of the daily log of feeding, behavioral observations, and mortality of organisms during holding and acclimation:

i. The water temperature of holding tanks;

ii. The air temperature in the culturing/holding room;

iii. Mortalities or organisms per holding tank;

iv. The analysis of laboratory grade waters as specified in 7:18-7.4(b);

v. The food and feeding schedule; and

vi. General observations of behavior and condition.

(j) The laboratory shall not accept custody of regulatory samples unless a chain-of-custody form is submitted with the samples, in accordance with 7:18-9.5(c).

1. Before accepting custody of a regulatory sample, the laboratory shall determine that the sample is properly labeled and has been collected, preserved, processed, stored and transported in accordance with the provisions of this subchapter. If the sample fails to meet those requirements, the laboratory shall indicate that failure on the chain-of-custody section of the sample request form or the chain-of-custody form;

2. The laboratory's sample custodian accepting responsibility for the sample shall sign the chain-of-custody form;

3. The laboratory shall have an internal chain-of-custody procedure or an alternate sample tracking procedure which establishes the integrity and completely tracks the custody of a sample during its lifetime in the laboratory; and

4. If the analysis was not performed at the environmental laboratory that first received the sample, the chain-of-custody form shall include the name, address and identification number of the New Jersey certified environmental laboratory to which the sample was forwarded.

(k) If a laboratory violates any of the requirements of this subchapter in the process of performing an acute toxicity test, the laboratory shall prefix the test result, that is, LC[50] or EC[50] value, with the letter "J," and describe the violation in the "remarks" section of the test report.

Notes

N.J. Admin. Code § 7:18-7.7