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Lab Test > Appendix N Bulk Milk Tanker Screening Test > Flashcards

Appendix N Bulk Milk Tanker Screening Test Flashcards

1
Q

What is the purpose of the CHARM® SL test?

A

To test for beta-lactam in raw commingled cow, sheep, water buffalo, and goat milk

This test is specifically designed for detecting antibiotic residues.

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2
Q

What is the incubation temperature and time for the SL beta-lactam test?

A

56+1°C for 8 minutes

This is the required condition for the SL beta-lactam test.

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3
Q

What is the incubation temperature and time for the SL3 beta-lactam test?

A

56+1°C for 3 minutes

The SL3 test has a shorter incubation time compared to the SL test.

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4
Q

What is the incubation temperature for the BL30SEC test?

A

56+1°C

The BL30SEC test is optional for SL and SL3.

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5
Q

What are the general requirements for the tests according to Appendix N?

A

See Appendix N General Requirements items 1-8 & 15

These items outline the foundational criteria for conducting the tests.

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6
Q

What records must be maintained daily for the incubator?

A

Temperature records

Daily checks are essential for ensuring the accuracy of the testing process.

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7
Q

What is required for the Charm EZ and EZ Protect in terms of temperature checks?

A

Printout acceptable for daily temperature check; annual accuracy check required

This ensures compliance and reliability in testing.

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8
Q

What should be done with the incubator lid when not running tests?

A

Lid closed (slightly sprung so that timer not active)

This prevents unnecessary activation of the timer and maintains the integrity of the equipment.

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9
Q

True or False: All tolerances for the tests are set at $5%.

A

True

This tolerance level is standard unless otherwise stated.

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10
Q

What is the significance of the Charm Sciences Strip Incubator’s temperature measuring device?

A

To ensure accurate incubation temperatures are maintained

Each incubator should have its own measuring device.

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11
Q

Fill in the blank: The Charm Sciences Strip Incubator requires a _______ if not included.

A

Timer

A timer is essential for tracking incubation times accurately.

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12
Q

What must be checked for accuracy before initial use and annually?

A

All test temperature measuring devices

This includes checking against a NIST traceable thermometer.

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13
Q

How accurate must temperature measuring devices be when checked at temperature(s) of use?

A

Accurate to $1°C

This ensures reliability in temperature measurements.

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14
Q

What information should be recorded/documented when checking temperature measuring devices?

A

Identification/location, date of check, temperature(s) checked, and correction factor(s)

Tagging individual devices with this information helps maintain accuracy and traceability.

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15
Q

To what nearest measurement should temperature measuring devices be read?

A

Nearest graduation/recording interval

Labs may optionally interpolate between graduations.

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16
Q

What must the software of temperature monitoring systems do?

A

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.

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17
Q

What must be documented when temperatures are out of acceptable range for more than two hours?

A

The event must be documented and corrective action taken as necessary

Records must be maintained for auditing purposes.

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18
Q

What is an optional feature for temperature monitoring systems in case of power failure?

A

A minimum two-day backup power source (battery/electrical)

This applies to the temperature monitoring system and/or all required sensors/probes.

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19
Q

How often should automatic temperature recording instruments be compared against an accurate thermometer?

A

Weekly

Maintaining records of these comparisons ensures ongoing accuracy.

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20
Q

What must temperature measuring devices be checked for at another location?

A

Accuracy

A copy of the record must be on-site.

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21
Q

Are dial thermometers used in the laboratory?

A

No

Dial thermometers are specifically noted as not being used in the laboratory.

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22
Q

What is the temperature range that refrigeration should maintain for samples?

A

0.0-4.5°C

This range is critical for preserving the integrity of samples.

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23
Q

What types of items should not be stored in refrigeration units?

A

Food or drink for consumption

Refrigeration is designated for milk, milk products, media, and reagents only.

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24
Q

How often should temperature records be downloaded from refrigeration units?

A

Daily

This includes recordings from two temperature measuring devices.

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25
Q

Where should temperature measuring devices be located in a refrigeration unit?

A

Upper and lower shelves

This ensures accurate temperature measurements throughout the unit.

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26
Q

What is the maximum temperature that a freezer should maintain?

A

-15°C or below

This temperature is necessary for the proper storage of frozen products.

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27
Q

What types of items should not be stored in freezer units?

A

Food or drink for consumption

Freezers are intended for storage of frozen milk products, controls, media, and reagents only.

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28
Q

How often should temperature records be downloaded from freezers?

A

Daily

This includes readings from the temperature measuring device immersed in liquid.

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29
Q

What is the appropriate weight capability for an electronic balance?

A

Appropriate for intended use

The balance must meet the specific requirements of the tasks it will perform.

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30
Q

What is the sensitivity required for accuracy checks of pipetting devices?

A

0.001g sensitivity

This sensitivity is suitable in most instances for checking pipetting accuracy.

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31
Q

How often should the balance calibration be checked if used for drug residue testing?

A

Within 30 days prior to the pipettor accuracy check

This ensures that the balance is accurate for critical testing.

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32
Q

What should a balance be free from to ensure proper function?

A

Excessive wear, filth, and corrosion

Maintaining the balance in good condition is essential for accurate measurements.

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33
Q

What is required for weights within class tolerance?

A

Checked annually by a qualified service representative

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34
Q

What must be maintained according to the guidelines?

A

Records

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35
Q

What identification is required for pipettors?

A

Etched with identification or imprinted serial numbers acceptable

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36
Q

What must be checked every 6 months for pipetting devices?

A

Accuracy with ten consecutive measurements

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37
Q

Fill in the blank: The average of all 10 measurements must be ______% of specified delivery volume.

A

±5%

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38
Q

How often should the Artel PCS Pipette Calibration System be used for accuracy checks?

A

Once every 6 months

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39
Q

What must be validated upon receipt of the PCS Calibration System?

A

Validate the instrument by following the manufacturer’s protocol

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40
Q

What is the frequency for performing an instrument calibration using the PCS Pipette System?

A

Every 30 days or just prior to use

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41
Q

What must be done with the results of the instrument calibration?

A

Record results and file Calibration Certificate (printout)

42
Q

What type of pipettors are required for NCIMS Accredited Laboratories?

A

Calibrated, Fixed Volume or Electronic Only

43
Q

What is necessary for appropriate pipetting technique?

A

Follow manufacturer’s instructions unless otherwise stated

44
Q

What is the requirement for pipetting device accuracy checks?

A

Checked on-site or at another location

45
Q

What type of tips should be used for pipettors?

A

Appropriate tips for pipettor(s) used

46
Q

What must be done for the accuracy check of pipettors?

A

Check accuracy with ten consecutive measurements by weight or by volume

47
Q

What is the minimum volume for using a class A graduated cylinder?

A

> 1.0 ml

48
Q

What is the storage requirement for reagent kits and instrument calibrator kits?

A

Store at room temperature

None

49
Q

What is the relationship between reagent blanks and sample solutions?

A

They are the same lot

None

50
Q

What must be followed for the PCS Pipette Calibration System Procedure?

A

Manufacturer’s Procedure Guide and instrument prompts

Maintain records

51
Q

What type of water is required for testing or as specified by the manufacturer?

A

Deionized Water or Equivalent

None

52
Q

What are the sample requirements for tanker samples?

A

Prevent contamination, ascertain temperature, secure representative sample

Temperature control sample must be taken if not tested immediately

53
Q

What must be recorded regarding the bulk milk tanker?

A

Temperature of bulk milk tanker

Maintain records

54
Q

What should be done with tanker samples upon arrival at the testing location?

A

Test promptly and record date and time

Determine sample temperature using a pre-cooled thermometer

55
Q

How can the temperature of the bulk milk tanker be used during testing?

A

As received and tested if testing begins without delay

None

56
Q

What should accompany samples that do not meet testing conditions?

A

Temperature control (TC)

If no TC, aliquot samples for testing

57
Q

What condition should the samples meet regarding leakage?

A

Samples should not be leaking

None

58
Q

What should be protected from direct contact with ice?

A

Tops of samples

None

59
Q

What should unprotected samples not be submerged in?

A

Water and/or ice or slush

60
Q

What must be run before use on each new lot of kits?

A

A positive and negative control

Must give appropriate results and maintain records

61
Q

How often should a negative and positive control be run?

A

Daily (on days testing) at each test site

Must give appropriate results; if not, re-run controls

62
Q

What should be done if performance controls do not give appropriate results?

A

Re-run controls and samples; if the problem persists, seek technical assistance

63
Q

What should be checked DAILY from the manufacturer?

A

Instrument calibration with check devices

Must give appropriate results; otherwise, discontinue testing

64
Q

What is the protocol if more than one analyst performs analysis?

A

Have a different analyst run performance check on a rotational basis

65
Q

What must be done with a positive tanker sample?

A

Re-test by the SAME analyst using the SAME test kit in DUPLICATE

Along with a positive and negative control

66
Q

What indicates that a tanker sample is PRESUMPTIVE POSITIVE?

A

If one or both duplicates is positive

The sample is referred to the designated certified laboratory

67
Q

What must be done with presumptive positive samples?

A

Forward to a certified laboratory

Not tested by screening facility

68
Q

What should be done if both duplicates of a sample are negative?

A

Milk may be received and processed; record and report as NOT FOUND

69
Q

What must be completed for Presumptive Positive samples?

A

Complete applicable section of Positive Report form and maintain records of all analyses

The Positive Report form is essential for tracking and reporting results.

70
Q

What should be done with the Positive Report form for Presumptive Positive samples?

A

Maintain a copy and forward the original to the certified laboratory or CIS

CIS refers to the Certification and Inspection Services.

71
Q

What conditions must be met for testing Presumptive Positive Tanker Samples?

A

The SAME sample is tested in DUPLICATE along with a positive and negative control

Testing in duplicate ensures the reliability of the results.

72
Q

What action is taken if one or both duplicates are positive?

A

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.

73
Q

What happens if both duplicates are negative?

A

Milk may be received and processed, recorded and reported as NOT FOUND

No producer trace back is performed in this case.

74
Q

What is required for Confirmed Positive samples?

A

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.

75
Q

What is the temperature range for samples during the Trace back of Producers on a Confirmed Positive Tanker?

A

Samples must be between 0.0 and 4.5°C

Proper temperature maintenance is crucial for sample integrity.

76
Q

What is the procedure for each producer sample in Trace back?

A

Perform an initial single test on each producer sample

Initial testing is critical for identifying potential sources of contamination.

77
Q

What must be done if a producer sample is positive?

A

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.

78
Q

What should be done if positive and/or negative control do not give appropriate results?

A

Re-run controls and samples, seek technical assistance if the problem persists

This step is essential to ensure the validity of the testing process.

79
Q

What is the implication if one or both duplicates is positive?

A

The producer sample(s) is (are) POSITIVE

80
Q

What should be recorded if both duplicates are negative?

A

Record and report the appropriate producer samples as NOT FOUND

81
Q

What should be completed for Confirmed Producer Positive samples?

A

Maintain a copy of the Positive Report form and forward the original to the State Regulatory Agency

82
Q

How should beta-lactam results be reported?

A

Report as Positive (+) for beta-lactam, specific drug or inhibitor when demonstrated

83
Q

What does Not Found (NF) indicate in reporting?

A

Report as Not Found (NF) when demonstrated

84
Q

What records must be maintained regarding test interpretations?

A

Record test performed, interpretation of unknowns (samples), and controls

85
Q

For how long must records, including all printouts, be maintained?

A

Records must be maintained for 2 years

86
Q

What should be accessible to analysts according to the Miscellaneous section?

A

Current Safety Data Sheets (SDS)

87
Q

What forms should be available in the laboratory?

A

Current, applicable survey forms and Positive Report forms with instructions

88
Q

What is required for personnel according to the guidelines?

A

Personnel must be adequately trained

89
Q

What participation is required as part of the procedures?

A

Required split/check sample participation

90
Q

What is the temperature and time setting for the SL beta-lactam test in the Charm Sciences Strip Incubator?

A

56+1°C for 8 minutes

This setting is specific for the SL beta-lactam test.

91
Q

What is the incubation time for the SL3 beta-lactam test?

A

56+1°C for 3 minutes

The SL3 beta-lactam test has a shorter incubation time.

92
Q

What is the purpose of the Charm EZ and EZ Protect in the testing process?

A

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.

93
Q

What must be done daily for the incubator used in the beta-lactam tests?

A

Check temperature and maintain records

Records of the daily temperature check are essential for compliance.

94
Q

What type of device is required for each incubator?

A

Temperature measuring device

This ensures accurate temperature monitoring during tests.

95
Q

What should be done with the lid of the incubator when not in use?

A

Keep the lid closed (slightly sprung so that timer not active)

This helps maintain the integrity of the testing environment.

96
Q

What are the general requirements stated in Appendix N for the bulk milk tanker screening test?

A

See Appendix N General Requirements items 1-8 & 15

These items provide foundational guidelines for testing procedures.

97
Q

What is the tolerance level for beta-lactam tests unless otherwise stated?

A

$5%

This tolerance applies to the measurement accuracy in testing.

98
Q

Fill in the blank: The Charm BL30SEC test is associated with _______ milk.

A

Raw Commingled Cow Milk

This indicates the specific type of milk tested with the BL30SEC method.

99
Q

What should be included in the incubator setup for testing?

A

Clean, properly maintained and located on a level surface

Proper setup is crucial for accurate test results.

100
Q

What is the significance of the annual accuracy check for the Charm EZ and EZ Protect?

A

To ensure the accuracy of temperature readings

This check is a regulatory requirement for testing equipment.

101
Q

True or False: The SL beta-lactam test requires an internal timer.

A

True

The internal timer is crucial for timing the incubation process.

102
Q

Appendix n bulk milk tanker screening test form

A

Lab Test (13 decks)

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