N.J. Admin. Code § 7:18-4.5

Current through Register Vol. 56, No. 21, November 4, 2024

Section 7:18-4.5 - Requirements for quality assurance/quality control program

(a) The laboratory shall develop and keep current a quality assurance/quality control manual. The laboratory shall not perform analyses of regulatory samples without having a current quality assurance/quality control manual covering the analysis in question. In the manual, the laboratory shall describe the following:

1. The procedures that the laboratory will use in meeting the quality control requirements of this chapter and all applicable DSAMs, including, but not limited to, requirements pertaining to laboratory equipment, instrumentation and supplies; and

2. The frequency with which the laboratory will perform the procedures listed pursuant to (a)1 above.

(b) The laboratory shall develop and implement a written methods manual containing a standard operating procedure (SOP) for each DSAM, in accordance with the criteria and procedures of the DSAM and this chapter. A laboratory shall not perform analyses using a DSAM unless it has developed and implemented such an SOP for the DSAM.

1. The laboratory shall update the manual to reflect any changes in the procedures practiced by the laboratory.

2. The laboratory shall keep copies of the methods manual in the immediate bench area of personnel engaged in the analysis of samples and related procedures within the Microbiological Testing Categories.

3. In the manual, the laboratory shall properly designate by revision number and date the standard operating procedure (SOP) for a specified analytical method for a particular type of analysis.

4. Changes to SOPs are effective only if:

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

ii. The manager, supervisor or quality assurance officer makes the change in writing, signed and dated by the manager, supervisor or quality assurance officer.

5. The laboratory shall make manufacturers' instruction manuals and any applicable regulations readily available to laboratory personnel at all times. Textbooks may be used to supplement written instructions, but may not be used in lieu thereof.

(c) A laboratory performing microbiological analyses shall conduct the quality control checks specified in the applicable DSAMs, and the following additional checks:

1. When the laboratory finds no positive samples for a certified method within a calendar quarter, the laboratory shall run a positive control sample for that method;

2. For each sample filtration series, the laboratory shall conduct a start and finish MF sterile control test of rinse water, media and supplies, using sterile rinse water as the sample. If the MF sterile control tests indicate contamination, then all data from the affected samples shall be rejected and the laboratory shall request immediate resampling of those waters involved in the laboratory error;

3. The laboratory shall complete the MPN test for drinking water samples on 10 percent of positive confirmed total coliform samples, except that gram staining need not be performed. However, if no positive tubes result from the tested drinking water samples, the laboratory shall complete the MPN test (and need not perform gram staining) quarterly on at least one water source for which results have been positive;

4. The laboratory shall cause its laboratory pure water to be tested, using approved methods, in accordance with (c)4i through v below.

i. The testing may be performed by the laboratory preparing the water, by another certified environmental laboratory, or by the manufacturer of the water if the laboratory purchases its laboratory pure water. If the laboratory purchases its laboratory pure water, it shall have each lot or batch of the water tested. Otherwise, the laboratory shall have its laboratory pure water tested at the frequency specified in Table 4.1 below;

ii. If the source water is chlorinated, the laboratory shall test the water for total residual chlorine using the DPD method. If the source water is not chlorinated, the laboratory need not test it for residual chlorine;

iii. The pour plate method (Method 9215B in SM18) shall be used to determine the heterotrophic plate count;

iv. In testing the bacteriological quality of the water, the laboratory shall use the methods described in SM18 or in EPA Microbiological Methods, p.200. The control water for testing bacteriological quality is double distilled water using a glass still; and

v. If the laboratory pure water does not meet the criteria set forth in Table 4.1 below, then the laboratory shall take action immediately to correct all failures to meet the criteria, and shall continue taking corrective action until a retest of the water shows that it meets the criteria.

Table 4.1

Requirements for Laboratory Pure Water

Parameter	Limits	Frequency
Conductivity	>0.5 megohms resistance or <2	Monthly
micromhos/cm at 25 [degree]C
Lead, Cadmium,	Not greater than 0.05 mg/L per	Annually
Chromium, Copper,	parameter. Collectively, no greater
Nickel, Zinc	than 0.1 mg/L
Total Chlorine, Residual	Nondetectable	Monthly
Heterotrophic Plate	<500/milliliter	Monthly
Count
Bacteriological Water	Ratio 0.8-3.0	Annually
Quality

5. Each certified environmental laboratory shall satisfactorily analyze one unknown PT sample per year, when available from a Department-approved PT sample provider, for the parameters within the Categories for which the environmental laboratory has received certification;

6. Any certified environmental laboratory analyzing samples for a public water facility shall examine a minimum of one positive control sample per month in addition to analyzing the required number of distribution samples and records maintained;

7. The laboratory shall record the temperature of air or water-jacketed incubators and water baths at least twice daily, with at least four hours between readings;

8. The laboratory shall record the contents, date, time, and temperature for each sterilization cycle of the autoclave;

9. The laboratory shall maintain records of hot air ovens showing the contents, date, time and temperature of each sterilization cycle;

10. The laboratory shall use only membrane filters that have been recommended or approved by the manufacturer for use in the analysis of water;

11. When the laboratory first uses a detergent or washing product, or changes the brand or type of washing product it uses, the rinsing process shall demonstrate that the detergent or washing product provides glassware free of toxic material by the inhibitory residue test as set forth in SM18 or in EPA Microbiological Methods, p. 199;

12. The laboratory shall check each batch of rinse water for sterility. The laboratory shall add 50 milliliters of water to a 50 milliliter volume of a double-strength non-selective broth (for example, tryptic soy, trypticase soy or tryptone broth) and then incubating the preparation at 35 degrees +/-0.5 degrees Celsius for 24 hours. At the end of the incubation period, the laboratory shall check the preparation for growth, and record the results. If bacterial growth is observed, the batch shall be discarded and a new batch prepared;

13. The laboratory shall check at least one sample container from each batch of laboratory sterilized sample containers or at least one sample container from each batch or lot of purchased sterile containers. The laboratory shall add approximately 25 milliliters of sterile non-selective broth to the container or containers being checked, and incubate the preparation at 35 degrees +/-0.5 degrees Celsius for 24 hours. At the end of the incubation period, the laboratory shall check the container for growth, and record the results. If bacterial growth is observed, the batch shall be resterilized and the results recorded;

14. The laboratory shall maintain annual service contracts or internal protocols on balances, autoclave, water still, and any other equipment requiring periodic servicing. The laboratory shall enter records of actual servicing in a log book. The laboratory shall make these contracts, protocols and service records available to the Department during inspections or upon the Department's request;

15. The laboratory shall maintain records of preparation of each batch of sterilized media. In the records, the laboratory shall include the lot number of the batch, date of preparation, sterilization time and temperature, final pH of each batch, and the preparing technician's name. The laboratory shall make these records available to the Department during inspections or upon the Department's request;

16. The laboratory shall label each bottle of dehydrated media with the date of receipt, and the date on which the bottle is first opened. The laboratory shall not use the media more than six months after it is first opened, provided however, that if the bottle is stored in a desiccator the media may be used for 12 months after it is first opened;

17. The laboratory shall record the lot number of packages of membrane filters and date of receipt;

18. The laboratory shall use heat-sensitive tapes, spore strips, spore ampules or a maximum registering thermometer during each autoclave cycle;

19. The laboratory shall label all reagents and solutions to identify them and indicate other information pertinent to identification, such as (when applicable) strength or concentration, storage requirements, preparation date, expiration date, and other information pertinent to identification; and

20. The laboratory shall not use any caked or discolored media, or any media that has exceeded the manufacturer's expiration date. The laboratory shall discard such media immediately.

N.J. Admin. Code § 7:18-4.5

Amended by 47 N.J.R. 782(a), effective 4/20/2015.