Appendix N Bulk Milk Tanket Screening Test Form

Question 1

What is the acceptable tolerance for general requirements?

Answer 1

$5%

This tolerance applies unless otherwise stated.

Question 2

What are the requirements for the work area during testing?

Answer 2

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

Preferred lighting is > 100 foot-candles.

Question 3

What is the minimum lighting requirement for testing areas?

Answer 3

> 50 foot-candles at working surface

Preferred lighting is > 100 foot-candles.

Question 4

What is not permitted in the immediate testing area?

Answer 4

Eating and drinking

This is to maintain cleanliness and prevent contamination.

Question 5

What are the storage space requirements?

Answer 5

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

This ensures organization and ease of access.

Question 6

What type of thermometer is required for temperature measuring?

Answer 6

NIST traceable thermometer or other certified device

Must be checked annually at ice point.

Question 7

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

Answer 7

Not greater than 1.0°C

For NCIMS Accredited Laboratories, it is 0.5°C.

Question 8

What types of thermometers can be used?

Answer 8

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

All must be in degrees centigrade.

Question 9

What is recommended for mercury thermometers?

Answer 9

Plastic lamination

This is to ensure safety and durability.

Question 10

What must be recorded for reference temperature measuring devices?

Answer 10

Serial #, Date of Certificate, Ice Point Date

This ensures traceability and compliance.

Question 11

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

Answer 11

Checked against NIST traceable thermometer

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

Question 12

How often must temperature measuring devices be checked for accuracy?

Answer 12

Annually

Results must be recorded/documented and individual devices tagged.

Question 13

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

Answer 13

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

This information is crucial for tracking and accountability.

Question 14

To what precision must temperature measuring devices be read?

Answer 14

Nearest graduation/recording interval

Labs may optionally interpolate between graduations.

Question 15

What frequency must Temperature Monitoring Systems record temperature readings?

Answer 15

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.

Question 16

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

Answer 16

Document the event and take corrective action as necessary

Maintain records of such incidents.

Question 17

What is the optional backup requirement for temperature monitoring systems?

Answer 17

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

This is important for maintaining functionality during power failures.

Question 18

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

Answer 18

Weekly

Records of these comparisons must be maintained.

Question 19

What must be checked for accuracy at another location?

Answer 19

Temperature measuring device(s)

Current and acceptable conditions must be documented.

Question 20

What type of thermometers are not used in the laboratory?

Answer 20

Dial thermometers

This is a specific requirement outlined in the guidelines.

Question 21

What is the temperature range for refrigeration of samples?

Answer 21

0.0-4.5°C

This range is critical for maintaining the integrity of samples.

Question 22

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

Answer 22

Milk or milk products, media, and reagents only

Food or drink for consumption is prohibited.

Question 23

What is the required temperature for a freezer?

Answer 23

-15°C or below

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

Question 24

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

Answer 24

Corrected temperature

This should be recorded from two measuring devices.

Question 25

Where should temperature measuring devices be located in refrigeration units?

Answer 25

Upper and lower shelves ## Footnote This ensures accurate temperature readings throughout the unit.

Question 26

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

Answer 26

0.001g sensitivity ## Footnote This level of sensitivity is suitable for most instances.

Question 27

How often should the electronic balance be checked for accuracy?

Answer 27

Monthly ## Footnote This ensures ongoing accuracy for pipetting devices.

Question 28

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

Answer 28

Class S or S1, or equivalent ASTM 1, 2, or 3 weights ## Footnote These weights correspond to the normal use of the balance.

Question 29

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

Answer 29

Free from excessive wear, filth, and corrosion ## Footnote This is essential for maintaining balance accuracy.

Question 30

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

Answer 30

Food or drink for consumption ## Footnote This ensures compliance with safety and health regulations.

Question 31

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

Answer 31

Appropriate for intended use ## Footnote This ensures that the balance can handle the weights required for the tasks.

Question 32

What is required for weights within class tolerance?

Answer 32

Checked annually by a qualified service representative ## Footnote Ensures compliance with accuracy standards.

Question 33

What must be maintained regarding pipettors?

Answer 33

Records ## Footnote Essential for tracking calibration and accuracy checks.

Question 34

What is a requirement for pipettors in NCIMS accredited laboratories?

Answer 34

Pipettors etched with identification and tagged with date accuracy checked ## Footnote Identification helps in maintaining accountability.

Question 35

What should be used with pipettors?

Answer 35

Appropriate tips ## Footnote Ensures proper function and accuracy.

Question 36

What must be followed unless otherwise stated regarding pipetting?

Answer 36

Manufacturer's instructions ## Footnote Adhering to guidelines ensures proper technique and results.

Question 37

How often should pipetting devices' accuracy be checked?

Answer 37

Every 6 months ## Footnote Regular checks help maintain accuracy over time.

Question 38

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

Answer 38

±5% of specified delivery volume ## Footnote Critical for ensuring the reliability of pipetting results.

Question 39

What alternative method can be used for checking pipetting accuracy?

Answer 39

Artel PCS Pipette Calibration System ## Footnote Provides a systematic approach to calibration.

Question 40

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

Answer 40

Validate the instrument by following the manufacturer's protocol ## Footnote Ensures the instrument is functioning correctly before use.

Question 41

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

Answer 41

Every 30 days or just prior to use ## Footnote Regular calibration is crucial for accurate measurements.

Question 42

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

Answer 42

Record results and file Calibration Certificate ## Footnote Documentation is important for compliance and traceability.

Question 43

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

Answer 43

Store at room temperature

Question 44

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

Answer 44

Records

Question 45

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

Answer 45

Deionized Water or Equivalent

Question 46

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

Answer 46

Prevent contamination with disinfectants from hands or other sources

Question 47

What must be recorded regarding the bulk milk tanker?

Answer 47

Temperature

Question 48

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

Answer 48

Take a temperature control (TC) sample

Question 49

What is the requirement for testing tanker samples upon arrival?

Answer 49

Test promptly and record date and time

Question 50

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

Answer 50

Insert a pre-cooled thermometer into temperature control

Question 51

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

Answer 51

False

Question 52

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

Answer 52

Temperature control (TC)

Question 53

Fill in the blank: Samples should not be _______.

Answer 53

leaking

Question 54

What should be protected from direct contact with ice?

Answer 54

Tops of samples

Question 55

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

Answer 55

Documentation by certified laboratory or CIS

Question 56

What should unprotected samples not be submerged in?

Answer 56

Water, ice, or slush

Question 57

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

Answer 57

A positive and negative control

Question 58

How often should a negative and positive control be run?

Answer 58

DAILY (on days testing)

Question 59

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

Answer 59

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

Question 60

What should be checked DAILY if available from the manufacturer?

Answer 60

Instrument calibration with check devices

Question 61

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

Answer 61

Discontinue testing and seek technical assistance

Question 62

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

Answer 62

Different analyst must run performance check on a rotational basis

Question 63

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

Answer 63

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

Question 64

What must the positive and negative controls give to proceed?

Answer 64

Appropriate results

Question 65

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

Answer 65

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

Question 66

What should presumptive positive samples be forwarded to?

Answer 66

A certified laboratory

Question 67

What should be done with both negative duplicates?

Answer 67

Milk may be received and processed, recorded as NOT FOUND

Question 68

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

Answer 68

certified laboratory

Question 69

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

Answer 69

False

Question 70

What must be completed for Presumptive Positive samples?

Answer 70

Complete applicable section of Positive Report form and maintain records of all analyses ## Footnote This includes forwarding the original report to the certified laboratory or CIS.

Question 71

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

Answer 71

Tested in DUPLICATE along with a positive and negative control ## Footnote A re-sample may be used at the State's discretion if the original sample is suspect.

Question 72

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

Answer 72

Re-run controls and samples, seek technical assistance if the problem persists ## Footnote This ensures the reliability of the test results.

Question 73

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

Answer 73

The tanker sample is CONFIRMED POSITIVE, and milk may not be processed ## Footnote State Regulatory must be contacted in this case.

Question 74

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

Answer 74

Milk may be received and processed, recorded and reported as NOT FOUND ## Footnote Producer trace back is not performed in this scenario.

Question 75

What must be maintained for Confirmed Positive samples?

Answer 75

A copy of the Positive Report form must be maintained and the original forwarded to the State Regulatory Agency ## Footnote This is a critical step for record-keeping and regulatory compliance.

Question 76

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

Answer 76

Between 0.0 and 4.5°C ## Footnote Maintaining proper temperature is crucial for sample integrity.

Question 77

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

Answer 77

Perform an initial single test on each producer sample ## Footnote Any positive producer sample must be re-tested.

Question 78

How is a positive producer sample re-tested?

Answer 78

The SAME sample is re-tested by the SAME analyst using the SAME test in DUPLICATE along with a positive and negative control ## Footnote This ensures consistency and accuracy in testing.

Question 79

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

Answer 79

POSITIVE

Question 80

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

Answer 80

NOT FOUND

Question 81

What is necessary to complete after a confirmed positive sample?

Answer 81

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

Question 82

What should be maintained for Confirmed Producer Positive samples?

Answer 82

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

Question 83

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

Answer 83

Report as Positive (+) when demonstrated

Question 84

What does Not Found (NF) indicate in reporting?

Answer 84

Report as Not Found when demonstrated

Question 85

What records must be kept for tests performed?

Answer 85

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

Question 86

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

Answer 86

2 years

Question 87

What must be accessible to analysts?

Answer 87

Current Safety Data Sheets (SDS)

Question 88

What forms should be available in the laboratory?

Answer 88

Current, applicable survey forms and Positive Report forms with instructions

Question 89

What is required for personnel in the laboratory?

Answer 89

Personnel adequately trained

Question 90

What participation is required in testing?

Answer 90

Required split/check sample participation

Question 91

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

Answer 91

2 years

Question 92

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

Answer 92

False