Appendix N Bulk Milk Tanker Screening Test Flashcards
What is the purpose of the CHARM® SL test?
To test for beta-lactam in raw commingled cow, sheep, water buffalo, and goat milk
This test is specifically designed for detecting antibiotic residues.
What is the incubation temperature and time for the SL beta-lactam test?
56+1°C for 8 minutes
This is the required condition for the SL beta-lactam test.
What is the incubation temperature and time for the SL3 beta-lactam test?
56+1°C for 3 minutes
The SL3 test has a shorter incubation time compared to the SL test.
What is the incubation temperature for the BL30SEC test?
56+1°C
The BL30SEC test is optional for SL and SL3.
What are the general requirements for the tests according to Appendix N?
See Appendix N General Requirements items 1-8 & 15
These items outline the foundational criteria for conducting the tests.
What records must be maintained daily for the incubator?
Temperature records
Daily checks are essential for ensuring the accuracy of the testing process.
What is required for the Charm EZ and EZ Protect in terms of temperature checks?
Printout acceptable for daily temperature check; annual accuracy check required
This ensures compliance and reliability in testing.
What should be done with the incubator lid when not running tests?
Lid closed (slightly sprung so that timer not active)
This prevents unnecessary activation of the timer and maintains the integrity of the equipment.
True or False: All tolerances for the tests are set at $5%.
True
This tolerance level is standard unless otherwise stated.
What is the significance of the Charm Sciences Strip Incubator’s temperature measuring device?
To ensure accurate incubation temperatures are maintained
Each incubator should have its own measuring device.
Fill in the blank: The Charm Sciences Strip Incubator requires a _______ if not included.
Timer
A timer is essential for tracking incubation times accurately.
What must be checked for accuracy before initial use and annually?
All test temperature measuring devices
This includes checking against a NIST traceable thermometer.
How accurate must temperature measuring devices be when checked at temperature(s) of use?
Accurate to $1°C
This ensures reliability in temperature measurements.
What information should be recorded/documented when checking temperature measuring devices?
Identification/location, date of check, temperature(s) checked, and correction factor(s)
Tagging individual devices with this information helps maintain accuracy and traceability.
To what nearest measurement should temperature measuring devices be read?
Nearest graduation/recording interval
Labs may optionally interpolate between graduations.
What must the software of temperature monitoring systems do?
Record temperature readings from each sensor/probe at the same or greater frequency as stipulated for MIG or AIG thermometers
Optionally, it can register an alert/alarm when out of the acceptable temperature range.
What must be documented when temperatures are out of acceptable range for more than two hours?
The event must be documented and corrective action taken as necessary
Records must be maintained for auditing purposes.
What is an optional feature for temperature monitoring systems in case of power failure?
A minimum two-day backup power source (battery/electrical)
This applies to the temperature monitoring system and/or all required sensors/probes.
How often should automatic temperature recording instruments be compared against an accurate thermometer?
Weekly
Maintaining records of these comparisons ensures ongoing accuracy.
What must temperature measuring devices be checked for at another location?
Accuracy
A copy of the record must be on-site.
Are dial thermometers used in the laboratory?
No
Dial thermometers are specifically noted as not being used in the laboratory.
What is the temperature range that refrigeration should maintain for samples?
0.0-4.5°C
This range is critical for preserving the integrity of samples.
What types of items should not be stored in refrigeration units?
Food or drink for consumption
Refrigeration is designated for milk, milk products, media, and reagents only.
How often should temperature records be downloaded from refrigeration units?
Daily
This includes recordings from two temperature measuring devices.
Where should temperature measuring devices be located in a refrigeration unit?
Upper and lower shelves
This ensures accurate temperature measurements throughout the unit.
What is the maximum temperature that a freezer should maintain?
-15°C or below
This temperature is necessary for the proper storage of frozen products.
What types of items should not be stored in freezer units?
Food or drink for consumption
Freezers are intended for storage of frozen milk products, controls, media, and reagents only.
How often should temperature records be downloaded from freezers?
Daily
This includes readings from the temperature measuring device immersed in liquid.
What is the appropriate weight capability for an electronic balance?
Appropriate for intended use
The balance must meet the specific requirements of the tasks it will perform.
What is the sensitivity required for accuracy checks of pipetting devices?
0.001g sensitivity
This sensitivity is suitable in most instances for checking pipetting accuracy.
How often should the balance calibration be checked if used for drug residue testing?
Within 30 days prior to the pipettor accuracy check
This ensures that the balance is accurate for critical testing.
What should a balance be free from to ensure proper function?
Excessive wear, filth, and corrosion
Maintaining the balance in good condition is essential for accurate measurements.
What is required for weights within class tolerance?
Checked annually by a qualified service representative
What must be maintained according to the guidelines?
Records
What identification is required for pipettors?
Etched with identification or imprinted serial numbers acceptable
What must be checked every 6 months for pipetting devices?
Accuracy with ten consecutive measurements
Fill in the blank: The average of all 10 measurements must be ______% of specified delivery volume.
±5%
How often should the Artel PCS Pipette Calibration System be used for accuracy checks?
Once every 6 months
What must be validated upon receipt of the PCS Calibration System?
Validate the instrument by following the manufacturer’s protocol
What is the frequency for performing an instrument calibration using the PCS Pipette System?
Every 30 days or just prior to use
What must be done with the results of the instrument calibration?
Record results and file Calibration Certificate (printout)
What type of pipettors are required for NCIMS Accredited Laboratories?
Calibrated, Fixed Volume or Electronic Only
What is necessary for appropriate pipetting technique?
Follow manufacturer’s instructions unless otherwise stated
What is the requirement for pipetting device accuracy checks?
Checked on-site or at another location
What type of tips should be used for pipettors?
Appropriate tips for pipettor(s) used
What must be done for the accuracy check of pipettors?
Check accuracy with ten consecutive measurements by weight or by volume
What is the minimum volume for using a class A graduated cylinder?
> 1.0 ml
What is the storage requirement for reagent kits and instrument calibrator kits?
Store at room temperature
None
What is the relationship between reagent blanks and sample solutions?
They are the same lot
None
What must be followed for the PCS Pipette Calibration System Procedure?
Manufacturer’s Procedure Guide and instrument prompts
Maintain records
What type of water is required for testing or as specified by the manufacturer?
Deionized Water or Equivalent
None
What are the sample requirements for tanker samples?
Prevent contamination, ascertain temperature, secure representative sample
Temperature control sample must be taken if not tested immediately
What must be recorded regarding the bulk milk tanker?
Temperature of bulk milk tanker
Maintain records
What should be done with tanker samples upon arrival at the testing location?
Test promptly and record date and time
Determine sample temperature using a pre-cooled thermometer
How can the temperature of the bulk milk tanker be used during testing?
As received and tested if testing begins without delay
None
What should accompany samples that do not meet testing conditions?
Temperature control (TC)
If no TC, aliquot samples for testing
What condition should the samples meet regarding leakage?
Samples should not be leaking
None
What should be protected from direct contact with ice?
Tops of samples
None
What should unprotected samples not be submerged in?
Water and/or ice or slush
What must be run before use on each new lot of kits?
A positive and negative control
Must give appropriate results and maintain records
How often should a negative and positive control be run?
Daily (on days testing) at each test site
Must give appropriate results; if not, re-run controls
What should be done if performance controls do not give appropriate results?
Re-run controls and samples; if the problem persists, seek technical assistance
What should be checked DAILY from the manufacturer?
Instrument calibration with check devices
Must give appropriate results; otherwise, discontinue testing
What is the protocol if more than one analyst performs analysis?
Have a different analyst run performance check on a rotational basis
What must be done with a positive tanker sample?
Re-test by the SAME analyst using the SAME test kit in DUPLICATE
Along with a positive and negative control
What indicates that a tanker sample is PRESUMPTIVE POSITIVE?
If one or both duplicates is positive
The sample is referred to the designated certified laboratory
What must be done with presumptive positive samples?
Forward to a certified laboratory
Not tested by screening facility
What should be done if both duplicates of a sample are negative?
Milk may be received and processed; record and report as NOT FOUND
What must be completed for Presumptive Positive samples?
Complete applicable section of Positive Report form and maintain records of all analyses
The Positive Report form is essential for tracking and reporting results.
What should be done with the Positive Report form for Presumptive Positive samples?
Maintain a copy and forward the original to the certified laboratory or CIS
CIS refers to the Certification and Inspection Services.
What conditions must be met for testing Presumptive Positive Tanker Samples?
The SAME sample is tested in DUPLICATE along with a positive and negative control
Testing in duplicate ensures the reliability of the results.
What action is taken if one or both duplicates are positive?
The tanker sample is CONFIRMED POSITIVE, milk may not be processed, and contact State Regulatory
Confirmed positive results indicate a failure to meet safety standards.
What happens if both duplicates are negative?
Milk may be received and processed, recorded and reported as NOT FOUND
No producer trace back is performed in this case.
What is required for Confirmed Positive samples?
Maintain a copy of the Positive Report form and forward the original to the State Regulatory Agency
This ensures that regulatory bodies are informed about confirmed issues.
What is the temperature range for samples during the Trace back of Producers on a Confirmed Positive Tanker?
Samples must be between 0.0 and 4.5°C
Proper temperature maintenance is crucial for sample integrity.
What is the procedure for each producer sample in Trace back?
Perform an initial single test on each producer sample
Initial testing is critical for identifying potential sources of contamination.
What must be done if a producer sample is positive?
The SAME sample must be re-tested by the SAME analyst using the SAME test in DUPLICATE along with a positive and negative control
Consistent testing conditions help verify the accuracy of the results.
What should be done if positive and/or negative control do not give appropriate results?
Re-run controls and samples, seek technical assistance if the problem persists
This step is essential to ensure the validity of the testing process.
What is the implication if one or both duplicates is positive?
The producer sample(s) is (are) POSITIVE
What should be recorded if both duplicates are negative?
Record and report the appropriate producer samples as NOT FOUND
What should be completed for Confirmed Producer Positive samples?
Maintain a copy of the Positive Report form and forward the original to the State Regulatory Agency
How should beta-lactam results be reported?
Report as Positive (+) for beta-lactam, specific drug or inhibitor when demonstrated
What does Not Found (NF) indicate in reporting?
Report as Not Found (NF) when demonstrated
What records must be maintained regarding test interpretations?
Record test performed, interpretation of unknowns (samples), and controls
For how long must records, including all printouts, be maintained?
Records must be maintained for 2 years
What should be accessible to analysts according to the Miscellaneous section?
Current Safety Data Sheets (SDS)
What forms should be available in the laboratory?
Current, applicable survey forms and Positive Report forms with instructions
What is required for personnel according to the guidelines?
Personnel must be adequately trained
What participation is required as part of the procedures?
Required split/check sample participation
What is the temperature and time setting for the SL beta-lactam test in the Charm Sciences Strip Incubator?
56+1°C for 8 minutes
This setting is specific for the SL beta-lactam test.
What is the incubation time for the SL3 beta-lactam test?
56+1°C for 3 minutes
The SL3 beta-lactam test has a shorter incubation time.
What is the purpose of the Charm EZ and EZ Protect in the testing process?
To display the message ‘Add milk to strip and close door’
This feature is required for the BL30SEC test and optional for SL and SL3 tests.
What must be done daily for the incubator used in the beta-lactam tests?
Check temperature and maintain records
Records of the daily temperature check are essential for compliance.
What type of device is required for each incubator?
Temperature measuring device
This ensures accurate temperature monitoring during tests.
What should be done with the lid of the incubator when not in use?
Keep the lid closed (slightly sprung so that timer not active)
This helps maintain the integrity of the testing environment.
What are the general requirements stated in Appendix N for the bulk milk tanker screening test?
See Appendix N General Requirements items 1-8 & 15
These items provide foundational guidelines for testing procedures.
What is the tolerance level for beta-lactam tests unless otherwise stated?
$5%
This tolerance applies to the measurement accuracy in testing.
Fill in the blank: The Charm BL30SEC test is associated with _______ milk.
Raw Commingled Cow Milk
This indicates the specific type of milk tested with the BL30SEC method.
What should be included in the incubator setup for testing?
Clean, properly maintained and located on a level surface
Proper setup is crucial for accurate test results.
What is the significance of the annual accuracy check for the Charm EZ and EZ Protect?
To ensure the accuracy of temperature readings
This check is a regulatory requirement for testing equipment.
True or False: The SL beta-lactam test requires an internal timer.
True
The internal timer is crucial for timing the incubation process.
Appendix n bulk milk tanker screening test form
