Current through Register Vol. 50, No. 9, September 20, 2024
A.
Laboratories conducting microbiological analysis of shellfish growing waters
for the Louisiana Molluscan Shellfish Program shall be officially designated as
part of the Louisiana state shellfish sanitation laboratory system. To be so
designated, laboratories shall be evaluated by the Laboratory Evaluation
Officer and shall maintain a satisfactory rating.
1. The Certified Laboratory shall be
evaluated by the FDA Laboratory Evaluation Officer, Department of Health and
Human Services, Public Health Service, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, Office of Food Safety, Division of Seafood
Safety, Shellfish Aquaculture and Policy Branch.
B. Evaluations shall be conducted at a
minimum of every three years or more frequently if necessary. Loss of
satisfactory reevaluation will result in loss of said designation. More
frequent evaluations will be required under the following circumstances:
1. a previous marginal or low evaluation
rating;
2. notable deviations from
acceptable or established methods;
3. major changes in workloads or
priorities;
4. a substantial
turnover of personnel;
5. at the
request of the FDA, Director, Shellfish and Aquaculture Policy Branch or the
Louisiana Molluscan Shellfish Program control authorities.
C. The laboratory shall meet all requirements
as described in this document and be found to be in substantial conformity with
the National Shellfish Sanitation (NSSP) as approved by the Louisiana Shellfish
Sanitation Program (LSSP).
D.
Analysts, supervisory and administrative personnel involved in the generation,
verification and reporting of laboratory data for the LSSP shall meet
qualifications described in the following Section.
E. The laboratory facilities shall meet the
following criteria.
1. Work space shall be
adequate (200 square ft., 2 and 6 linear feet of bench/analyst) to accommodate
peak workloads.
2. Work space shall
include sufficient bench top area for processing samples, storage space for
media, glassware, and portable equipment, floor space for stationary equipment
and instrumentation, and associated areas for cleaning glassware and for
sterilizing materials.
3.
Facilities shall be clean, air-conditioned, and have adequate lighting at the
bench top (100 ft. candles).
F. The laboratory shall demonstrate a
conscious effort to safeguard against electrical, fire and accidental chemical
spills and to minimize microbiological hazards, facility deficiencies and
equipment failures.
G. The
laboratory shall have an established quality control program to substantiate
the validity of analytical data. The quality control procedures in effect shall
conform to the criteria stipulated in the current edition of Standard
Methods for the Examination of Water and Wastewater and/or APHA
Recommended Procedures for the Examination of Sea Water and Shellfish
and Official Methods of Analysis of the Association of Official
Analytical Chemists (A.O.A.C.). Compliance with procedures shall be recorded
and documented and records maintained by or be accessible to the laboratory for
a period of five years.
H. The
following constitute minimal quality assurance procedure requirements for the
laboratory.
1. Water deionization units shall
be monitored daily continuously with a conductivity meter and analyzed at least
annually for trace metals. Cartridges shall be replaced at intervals
recommended by the manufacturer or as indicated by analytical results. Units
shall be monitored for effectiveness in removing bacterial contamination
monthly with heterotrophic plate counts and filters shall be changed when the
count exceeds 1,000/ml.
2. The
suitability and bacteriological quality of pure water used in the analysis of
shellfish growing waters shall be tested annually and shall meet the acceptable
limits of water quality as stipulated in the table of requirements for quality
of purified water used in microbiology testing, current edition of
Standard Methods for the Examination of Water and
Wastewater.
3. Media
dispensing units shall be checked for accuracy of dispensing with a graduated
cylinder at the start of each volume change and periodically through extended
runs.
4. The performance of hot air
ovens shall be tested for performance quarterly with commercially available
spore strips or spore. The temperature shall be monitored and recorded with a
thermometer accurate to 160° to 180°C range. Heat-indicating tapes should be
used to identify supplies and material that have been exposed to sterilization
temperatures.
5. The temperature,
pressure, and time for each autoclave run shall be recorded. Operating
temperature shall be checked weekly with a minimum/maximum thermometer and the
autoclave performance shall be tested with spore strips or suspensions monthly.
Heat-sensitive tape shall be used to identify supplies and material that have
been sterilized.
6. The temperature
of air incubators shall be checked and recorded twice daily (morning and
afternoon) on the shelf areas in use. If a glass thermometer is used, the bulb
and stem shall be submerged in water or glycerin to the stem mark. Ideally, a
recording thermometer and an alarm system should be used. Locate incubator
where room temperature is in the range of 16°C.
7. Batches of clean glassware shall be spot
checked for pH reaction as follows: Add a few drops of 0.04 percent Bromothymol
blue or other pH indicator and observe the color reaction. Bromothymol blue may
be yellow (acid) to blue-green (neutral) to blue (alkaline), in the pH range of
6.5 to 7.3.
8. Glassware and
prewashed, presterilized plasticware shall be tested annually and before using
a new supply of detergent for inhibitory residues from wetting agents or
detergents that may contain bacteriostatic or inhibiting substances according
to procedures in the current edition of Standard Methods for the
Examination of Water and Wastewater.
9. Each new lot of media shall be checked
with known positive and negative control cultures for the organisms under test.
For media prepared, the date of preparation, type of medium, lot number,
sterilization and temperature, final pH and preparing technician shall be
recorded.
10. A representative
sample from each batch of media, dilution water and buffers and glassware shall
be verified for sterility according to procedures in the current edition of
Standard Methods for the Examination of Water and
Wastewater.
11. In
laboratories where there is more than one analyst, analysts shall make parallel
analyses on at least one positive sample quarterly.
12. Balances shall be calibrated monthly
using Class S or S-1 reference weights or weights traceable to Class S or S-1
reference weights. If non-reference weights are used they shall be calibrated
annually with Class S or S-1 reference weights.
13. Glass/mercury thermometer calibration
should be checked annually against a reference National Institute of Standards
and Technology (NIST) thermometer or one which meets the requirements of NIST
monograph 150, 2020 edition, published August 2020.
14. The temperature of refrigerators used to
store samples, media, reagents and other laboratory supplies shall be recorded
once daily for days in use.
15. Air
quality in the laboratory should be monitored weekly with air density plates
and bench tops with RODAC plates or the swab method.
16. Electrometric pH meters shall be
standardized each use period with pH 7.0 standard buffer.
17. The accurate transfer of test result data
from the bench worksheet to the final report and/or electronic information
storage and retrieval systems shall be verified and initialed by the
analyst.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:4.A.(1),
R.S.
40:5.A.(2)(3)(5)(7)(9)(15)(17)(19)(20) and
R.S.
40:5.3.
