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Lab Test > Appendix N Bulk Milk Tanket Screening Test Form > Flashcards

Appendix N Bulk Milk Tanket Screening Test Form Flashcards

1
Q

What is the acceptable tolerance for general requirements?

A

$5%

This tolerance applies unless otherwise stated.

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2
Q

What are the requirements for the work area during testing?

A

Ample working space and utilities, clean, well-ventilated, adequate lighting

Preferred lighting is > 100 foot-candles.

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3
Q

What is the minimum lighting requirement for testing areas?

A

> 50 foot-candles at working surface

Preferred lighting is > 100 foot-candles.

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4
Q

What is not permitted in the immediate testing area?

A

Eating and drinking

This is to maintain cleanliness and prevent contamination.

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5
Q

What are the storage space requirements?

A

Cabinets, drawers, and shelves adequate; areas neat, clean and orderly

This ensures organization and ease of access.

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6
Q

What type of thermometer is required for temperature measuring?

A

NIST traceable thermometer or other certified device

Must be checked annually at ice point.

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7
Q

What is the maximum graduation/recording interval for temperature measuring devices?

A

Not greater than 1.0°C

For NCIMS Accredited Laboratories, it is 0.5°C.

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8
Q

What types of thermometers can be used?

A

Mercury-in-glass, alcohol/spirit-in-glass, or electronic/digital thermometers

All must be in degrees centigrade.

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9
Q

What is recommended for mercury thermometers?

A

Plastic lamination

This is to ensure safety and durability.

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10
Q

What must be recorded for reference temperature measuring devices?

A

Serial #, Date of Certificate, Ice Point Date

This ensures traceability and compliance.

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11
Q

What is the accuracy requirement for temperature measuring devices before initial use?

A

Checked against NIST traceable thermometer

Devices must be accurate to $1°C when checked at temperature(s) of use.

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12
Q

How often must temperature measuring devices be checked for accuracy?

A

Annually

Results must be recorded/documented and individual devices tagged.

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13
Q

What information must be included on the tags of temperature measuring devices?

A

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

This information is crucial for tracking and accountability.

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14
Q

To what precision must temperature measuring devices be read?

A

Nearest graduation/recording interval

Labs may optionally interpolate between graduations.

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15
Q

What frequency must Temperature Monitoring Systems record temperature readings?

A

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.

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16
Q

What action must be taken if temperatures are out of the acceptable range for more than two hours?

A

Document the event and take corrective action as necessary

Maintain records of such incidents.

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17
Q

What is the optional backup requirement for temperature monitoring systems?

A

Minimum two-day backup power source (battery/electrical)

This is important for maintaining functionality during power failures.

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18
Q

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

A

Weekly

Records of these comparisons must be maintained.

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19
Q

What must be checked for accuracy at another location?

A

Temperature measuring device(s)

Current and acceptable conditions must be documented.

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20
Q

What type of thermometers are not used in the laboratory?

A

Dial thermometers

This is a specific requirement outlined in the guidelines.

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21
Q

What is the temperature range for refrigeration of samples?

A

0.0-4.5°C

This range is critical for maintaining the integrity of samples.

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22
Q

What items are allowed to be stored in a refrigerator according to the guidelines?

A

Milk or milk products, media, and reagents only

Food or drink for consumption is prohibited.

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23
Q

What is the required temperature for a freezer?

A

-15°C or below

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

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24
Q

What must be recorded daily from temperature measuring devices in refrigeration and freezing units?

A

Corrected temperature

This should be recorded from two measuring devices.

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25
Q

Where should temperature measuring devices be located in refrigeration units?

A

Upper and lower shelves

This ensures accurate temperature readings throughout the unit.

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26
Q

What is the appropriate sensitivity for checking pipetting devices using an electronic balance?

A

0.001g sensitivity

This level of sensitivity is suitable for most instances.

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27
Q

How often should the electronic balance be checked for accuracy?

A

Monthly

This ensures ongoing accuracy for pipetting devices.

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28
Q

What type of weights should be used for verifying balance calibration?

A

Class S or S1, or equivalent ASTM 1, 2, or 3 weights

These weights correspond to the normal use of the balance.

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29
Q

What conditions must an electronic balance meet to be considered appropriate for use?

A

Free from excessive wear, filth, and corrosion

This is essential for maintaining balance accuracy.

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30
Q

What is prohibited from being stored in both refrigeration and freezer units?

A

Food or drink for consumption

This ensures compliance with safety and health regulations.

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31
Q

What is the weight capability of an electronic balance supposed to be?

A

Appropriate for intended use

This ensures that the balance can handle the weights required for the tasks.

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32
Q

What is required for weights within class tolerance?

A

Checked annually by a qualified service representative

Ensures compliance with accuracy standards.

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33
Q

What must be maintained regarding pipettors?

A

Records

Essential for tracking calibration and accuracy checks.

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34
Q

What is a requirement for pipettors in NCIMS accredited laboratories?

A

Pipettors etched with identification and tagged with date accuracy checked

Identification helps in maintaining accountability.

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35
Q

What should be used with pipettors?

A

Appropriate tips

Ensures proper function and accuracy.

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36
Q

What must be followed unless otherwise stated regarding pipetting?

A

Manufacturer’s instructions

Adhering to guidelines ensures proper technique and results.

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37
Q

How often should pipetting devices’ accuracy be checked?

A

Every 6 months

Regular checks help maintain accuracy over time.

38
Q

What is the acceptable average of ten measurements for pipetting accuracy?

A

±5% of specified delivery volume

Critical for ensuring the reliability of pipetting results.

39
Q

What alternative method can be used for checking pipetting accuracy?

A

Artel PCS Pipette Calibration System

Provides a systematic approach to calibration.

40
Q

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

A

Validate the instrument by following the manufacturer’s protocol

Ensures the instrument is functioning correctly before use.

41
Q

How often must instrument calibration be performed using the PCS system?

A

Every 30 days or just prior to use

Regular calibration is crucial for accurate measurements.

42
Q

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

A

Record results and file Calibration Certificate

Documentation is important for compliance and traceability.

43
Q

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

A

Store at room temperature

44
Q

What should be maintained according to the PCS Pipette Calibration System Procedure?

A

Records

45
Q

What type of water should be used according to the manufacturer?

A

Deionized Water or Equivalent

46
Q

What is the first requirement for sample collection from a bulk milk tanker?

A

Prevent contamination with disinfectants from hands or other sources

47
Q

What must be recorded regarding the bulk milk tanker?

A

Temperature

48
Q

What must be done if a sample will not be tested without delay?

A

Take a temperature control (TC) sample

49
Q

What is the requirement for testing tanker samples upon arrival?

A

Test promptly and record date and time

50
Q

How should the temperature of the bulk milk tanker be determined?

A

Insert a pre-cooled thermometer into temperature control

51
Q

True or False: Pre-cooling of electronic/digital thermometer probes is necessary before measuring temperature.

A

False

52
Q

What must accompany samples according to Appendix N Producer Trace Back Samples?

A

Temperature control (TC)

53
Q

Fill in the blank: Samples should not be _______.

A

leaking

54
Q

What should be protected from direct contact with ice?

A

Tops of samples

55
Q

What condition allows for the testing of samples not meeting outlined conditions?

A

Documentation by certified laboratory or CIS

56
Q

What should unprotected samples not be submerged in?

A

Water, ice, or slush

57
Q

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

A

A positive and negative control

58
Q

How often should a negative and positive control be run?

A

DAILY (on days testing)

59
Q

What should be done if the negative and positive controls do not give appropriate results?

A

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

60
Q

What should be checked DAILY if available from the manufacturer?

A

Instrument calibration with check devices

61
Q

What action should be taken if the instrument calibration does not give appropriate results?

A

Discontinue testing and seek technical assistance

62
Q

If more than one analyst performs analysis, what is required?

A

Different analyst must run performance check on a rotational basis

63
Q

What is the first step in verifying initial positive tanker samples?

A

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

64
Q

What must the positive and negative controls give to proceed?

A

Appropriate results

65
Q

What should be done if one or both duplicates are positive?

A

The tanker sample is PRESUMPTIVE POSITIVE and referred to a certified laboratory

66
Q

What should presumptive positive samples be forwarded to?

A

A certified laboratory

67
Q

What should be done with both negative duplicates?

A

Milk may be received and processed, recorded as NOT FOUND

68
Q

Fill in the blank: Presumptive positive samples must be forwarded to a _______.

A

certified laboratory

69
Q

True or False: Producer samples must be tested by the screening facility.

A

False

70
Q

What must be completed for Presumptive Positive samples?

A

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.

71
Q

What is done with the SAME sample for Confirmation of Presumptive Positive Tanker Samples?

A

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.

72
Q

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

A

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

This ensures the reliability of the test results.

73
Q

What is the outcome if one or both duplicates of a tanker sample are positive?

A

The tanker sample is CONFIRMED POSITIVE, and milk may not be processed

State Regulatory must be contacted in this case.

74
Q

What happens if both duplicates of a tanker sample are negative?

A

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

Producer trace back is not performed in this scenario.

75
Q

What must be maintained for Confirmed Positive samples?

A

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.

76
Q

What temperature range must samples be maintained within for tracing back producers on a Confirmed Positive Tanker?

A

Between 0.0 and 4.5°C

Maintaining proper temperature is crucial for sample integrity.

77
Q

What is the procedure for each producer sample during trace back?

A

Perform an initial single test on each producer sample

Any positive producer sample must be re-tested.

78
Q

How is a positive producer sample re-tested?

A

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.

79
Q

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

A

POSITIVE

80
Q

What should be recorded and reported if both duplicates are negative?

A

NOT FOUND

81
Q

What is necessary to complete after a confirmed positive sample?

A

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

82
Q

What should be maintained for Confirmed Producer Positive samples?

A

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

83
Q

How should beta-lactam specific drug or inhibitor results be reported?

A

Report as Positive (+) when demonstrated

84
Q

What does Not Found (NF) indicate in reporting?

A

Report as Not Found when demonstrated

85
Q

What records must be kept for tests performed?

A

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

86
Q

For how long should records, including printouts, be maintained?

A

2 years

87
Q

What must be accessible to analysts?

A

Current Safety Data Sheets (SDS)

88
Q

What forms should be available in the laboratory?

A

Current, applicable survey forms and Positive Report forms with instructions

89
Q

What is required for personnel in the laboratory?

A

Personnel adequately trained

90
Q

What participation is required in testing?

A

Required split/check sample participation

91
Q

Fill in the blank: Records must be maintained for _______.

A

2 years

92
Q

True or False: Positive Report forms are not necessary for laboratory operations.

A

False

Lab Test (13 decks)

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