Appendix N Bulk Milk Tanket Screening Test Form Flashcards
What is the acceptable tolerance for general requirements?
$5%
This tolerance applies unless otherwise stated.
What are the requirements for the work area during testing?
Ample working space and utilities, clean, well-ventilated, adequate lighting
Preferred lighting is > 100 foot-candles.
What is the minimum lighting requirement for testing areas?
> 50 foot-candles at working surface
Preferred lighting is > 100 foot-candles.
What is not permitted in the immediate testing area?
Eating and drinking
This is to maintain cleanliness and prevent contamination.
What are the storage space requirements?
Cabinets, drawers, and shelves adequate; areas neat, clean and orderly
This ensures organization and ease of access.
What type of thermometer is required for temperature measuring?
NIST traceable thermometer or other certified device
Must be checked annually at ice point.
What is the maximum graduation/recording interval for temperature measuring devices?
Not greater than 1.0°C
For NCIMS Accredited Laboratories, it is 0.5°C.
What types of thermometers can be used?
Mercury-in-glass, alcohol/spirit-in-glass, or electronic/digital thermometers
All must be in degrees centigrade.
What is recommended for mercury thermometers?
Plastic lamination
This is to ensure safety and durability.
What must be recorded for reference temperature measuring devices?
Serial #, Date of Certificate, Ice Point Date
This ensures traceability and compliance.
What is the accuracy requirement for temperature measuring devices before initial use?
Checked against NIST traceable thermometer
Devices must be accurate to $1°C when checked at temperature(s) of use.
How often must temperature measuring devices be checked for accuracy?
Annually
Results must be recorded/documented and individual devices tagged.
What information must be included on the tags of temperature measuring devices?
Identification/location, date of check, temperature(s) checked, correction factors
This information is crucial for tracking and accountability.
To what precision must temperature measuring devices be read?
Nearest graduation/recording interval
Labs may optionally interpolate between graduations.
What frequency must Temperature Monitoring Systems record temperature readings?
Same or greater frequency as stipulated for MIG or AIG thermometers
Optionally, set to register an alert/alarm when out of the acceptable temperature range.
What action must be taken if temperatures are out of the acceptable range for more than two hours?
Document the event and take corrective action as necessary
Maintain records of such incidents.
What is the optional backup requirement for temperature monitoring systems?
Minimum two-day backup power source (battery/electrical)
This is important for maintaining functionality during power failures.
How often must automatic temperature recording instruments be compared against an accurate thermometer?
Weekly
Records of these comparisons must be maintained.
What must be checked for accuracy at another location?
Temperature measuring device(s)
Current and acceptable conditions must be documented.
What type of thermometers are not used in the laboratory?
Dial thermometers
This is a specific requirement outlined in the guidelines.
What is the temperature range for refrigeration of samples?
0.0-4.5°C
This range is critical for maintaining the integrity of samples.
What items are allowed to be stored in a refrigerator according to the guidelines?
Milk or milk products, media, and reagents only
Food or drink for consumption is prohibited.
What is the required temperature for a freezer?
-15°C or below
This temperature is necessary for the proper storage of frozen products.
What must be recorded daily from temperature measuring devices in refrigeration and freezing units?
Corrected temperature
This should be recorded from two measuring devices.
Where should temperature measuring devices be located in refrigeration units?
Upper and lower shelves
This ensures accurate temperature readings throughout the unit.
What is the appropriate sensitivity for checking pipetting devices using an electronic balance?
0.001g sensitivity
This level of sensitivity is suitable for most instances.
How often should the electronic balance be checked for accuracy?
Monthly
This ensures ongoing accuracy for pipetting devices.
What type of weights should be used for verifying balance calibration?
Class S or S1, or equivalent ASTM 1, 2, or 3 weights
These weights correspond to the normal use of the balance.
What conditions must an electronic balance meet to be considered appropriate for use?
Free from excessive wear, filth, and corrosion
This is essential for maintaining balance accuracy.
What is prohibited from being stored in both refrigeration and freezer units?
Food or drink for consumption
This ensures compliance with safety and health regulations.
What is the weight capability of an electronic balance supposed to be?
Appropriate for intended use
This ensures that the balance can handle the weights required for the tasks.
What is required for weights within class tolerance?
Checked annually by a qualified service representative
Ensures compliance with accuracy standards.
What must be maintained regarding pipettors?
Records
Essential for tracking calibration and accuracy checks.
What is a requirement for pipettors in NCIMS accredited laboratories?
Pipettors etched with identification and tagged with date accuracy checked
Identification helps in maintaining accountability.
What should be used with pipettors?
Appropriate tips
Ensures proper function and accuracy.
What must be followed unless otherwise stated regarding pipetting?
Manufacturer’s instructions
Adhering to guidelines ensures proper technique and results.
How often should pipetting devices’ accuracy be checked?
Every 6 months
Regular checks help maintain accuracy over time.
What is the acceptable average of ten measurements for pipetting accuracy?
±5% of specified delivery volume
Critical for ensuring the reliability of pipetting results.
What alternative method can be used for checking pipetting accuracy?
Artel PCS Pipette Calibration System
Provides a systematic approach to calibration.
What must be done upon receipt of the PCS Calibration System?
Validate the instrument by following the manufacturer’s protocol
Ensures the instrument is functioning correctly before use.
How often must instrument calibration be performed using the PCS system?
Every 30 days or just prior to use
Regular calibration is crucial for accurate measurements.
What should be done with the results of the instrument calibration?
Record results and file Calibration Certificate
Documentation is important for compliance and traceability.
What is the storage requirement for reagent kits and instrument calibrator kits?
Store at room temperature
What should be maintained according to the PCS Pipette Calibration System Procedure?
Records
What type of water should be used according to the manufacturer?
Deionized Water or Equivalent
What is the first requirement for sample collection from a bulk milk tanker?
Prevent contamination with disinfectants from hands or other sources
What must be recorded regarding the bulk milk tanker?
Temperature
What must be done if a sample will not be tested without delay?
Take a temperature control (TC) sample
What is the requirement for testing tanker samples upon arrival?
Test promptly and record date and time
How should the temperature of the bulk milk tanker be determined?
Insert a pre-cooled thermometer into temperature control
True or False: Pre-cooling of electronic/digital thermometer probes is necessary before measuring temperature.
False
What must accompany samples according to Appendix N Producer Trace Back Samples?
Temperature control (TC)
Fill in the blank: Samples should not be _______.
leaking
What should be protected from direct contact with ice?
Tops of samples
What condition allows for the testing of samples not meeting outlined conditions?
Documentation by certified laboratory or CIS
What should unprotected samples not be submerged in?
Water, ice, or slush
What must be run before use on each new lot of kits?
A positive and negative control
How often should a negative and positive control be run?
DAILY (on days testing)
What should be done if the negative and positive controls do not give appropriate results?
Re-run controls and samples; seek technical assistance if problem persists
What should be checked DAILY if available from the manufacturer?
Instrument calibration with check devices
What action should be taken if the instrument calibration does not give appropriate results?
Discontinue testing and seek technical assistance
If more than one analyst performs analysis, what is required?
Different analyst must run performance check on a rotational basis
What is the first step in verifying initial positive tanker samples?
Re-test the SAME sample by the SAME analyst using the SAME test kit in DUPLICATE
What must the positive and negative controls give to proceed?
Appropriate results
What should be done if one or both duplicates are positive?
The tanker sample is PRESUMPTIVE POSITIVE and referred to a certified laboratory
What should presumptive positive samples be forwarded to?
A certified laboratory
What should be done with both negative duplicates?
Milk may be received and processed, recorded as NOT FOUND
Fill in the blank: Presumptive positive samples must be forwarded to a _______.
certified laboratory
True or False: Producer samples must be tested by the screening facility.
False
What must be completed for Presumptive Positive samples?
Complete applicable section of Positive Report form and maintain records of all analyses
This includes forwarding the original report to the certified laboratory or CIS.
What is done with the SAME sample for Confirmation of Presumptive Positive Tanker Samples?
Tested in DUPLICATE along with a positive and negative control
A re-sample may be used at the State’s discretion if the original sample is suspect.
What should be done if positive and/or negative controls do not give appropriate results?
Re-run controls and samples, seek technical assistance if the problem persists
This ensures the reliability of the test results.
What is the outcome if one or both duplicates of a tanker sample are positive?
The tanker sample is CONFIRMED POSITIVE, and milk may not be processed
State Regulatory must be contacted in this case.
What happens if both duplicates of a tanker sample are negative?
Milk may be received and processed, recorded and reported as NOT FOUND
Producer trace back is not performed in this scenario.
What must be maintained for Confirmed Positive samples?
A copy of the Positive Report form must be maintained and the original forwarded to the State Regulatory Agency
This is a critical step for record-keeping and regulatory compliance.
What temperature range must samples be maintained within for tracing back producers on a Confirmed Positive Tanker?
Between 0.0 and 4.5°C
Maintaining proper temperature is crucial for sample integrity.
What is the procedure for each producer sample during trace back?
Perform an initial single test on each producer sample
Any positive producer sample must be re-tested.
How is a positive producer sample re-tested?
The SAME sample is re-tested by the SAME analyst using the SAME test in DUPLICATE along with a positive and negative control
This ensures consistency and accuracy in testing.
What is the outcome if one or both duplicates is positive?
POSITIVE
What should be recorded and reported if both duplicates are negative?
NOT FOUND
What is necessary to complete after a confirmed positive sample?
Complete applicable section of Positive Report form and maintain records of all analysis
What should be maintained for Confirmed Producer Positive samples?
A copy of the Positive Report form and forward the original to the State Regulatory Agency
How should beta-lactam specific drug or inhibitor results be reported?
Report as Positive (+) when demonstrated
What does Not Found (NF) indicate in reporting?
Report as Not Found when demonstrated
What records must be kept for tests performed?
Record test performed, interpretation of unknowns (samples) and controls
For how long should records, including printouts, be maintained?
2 years
What must be accessible to analysts?
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 in the laboratory?
Personnel adequately trained
What participation is required in testing?
Required split/check sample participation
Fill in the blank: Records must be maintained for _______.
2 years
True or False: Positive Report forms are not necessary for laboratory operations.
False
