Fossomatic Bacsomatic Flashcards

1
Q

What does FOSSOMATIC BACSOMATIC ™ analyze?

A

Raw Commingled Cow Milk

This is the primary focus of the FOSSOMATIC BACSOMATIC ™ testing system.

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2
Q

What are the IMS numbers associated with FOSSOMATIC BACSOMATIC ™?

A

7e & 16h

These numbers indicate specific standards or requirements for the system.

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3
Q

What is the tolerance level mentioned in the document?

A

$5%

This tolerance applies unless otherwise stated in the document.

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4
Q

What are the sample requirements for raw milk testing?

A

See CP items 33 & 34

Specific guidelines for handling and testing raw milk samples.

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5
Q

How long can un-preserved raw milk samples be run for bacteria counting after collection?

A

Up to 60 hours

This is the time frame for testing raw milk for bacteria without preservation.

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6
Q

What is the maximum time frame for SCC counting with un-preserved samples?

A

Up to 72 hours

This refers to somatic cell count testing.

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7
Q

How long can preserved samples be tested for SCC counting?

A

Up to 7 days

Preserved with 0.02% 2-bromo-2-nitropropane-1,3-diol or 0.05% potassium dichromate.

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8
Q

What is required for simultaneous bacteria and SCC counting?

A

Criteria for bacteria counting apply

This means the same conditions for bacteria counting also apply to SCC.

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9
Q

What is a prerequisite for testing with the Standard Plate Count?

A

Comparative Test with Standard Plate Count with Approved Media

This involves testing 25 samples in duplicate.

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10
Q

How many samples should be tested in duplicate for the comparative test?

A

25 samples

This is required for accurate comparison using the SPC or PAC methods.

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11
Q

Who must perform the comparisons for the tests?

A

Certified analysts

Analysts must be certified for SPC or PAC methods.

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12
Q

What must be included in the QC records regarding test comparisons?

A

Copy of comparisons and results

These should be easily accessible in the laboratory.

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13
Q

Is a Comparative Test with DMSCC required for certification of analysts?

A

No, if purchasing standards from a certified provider

This indicates a specific exemption in the certification process.

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14
Q

Who must be certified for DMSCC?

A

Analyst(s)

Certification is mandatory for those performing DMSCC.

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15
Q

What is the first step each analyst must perform for the ESCC test?

A

Test 4 samples in triplicate for both DMSCC and ESCC

The samples should be in the ranges of 100K-200K, 300K-500K, 600K-800K, and 900K-1.2M.

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16
Q

Who must evaluate the results of the ESCC test?

A

FDA/LPET LEO or LEO

Results must be shown to be acceptable prior to official use of the test in the laboratory.

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17
Q

What must be kept in the QC record regarding the ESCC test?

A

Copy of comparison and results

This must be kept for as long as the analyst is certified.

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18
Q

What is the conductivity requirement for deionized water used in the test?

A

Less than 2uS/cm

This is specified in CP item 24.c.3.

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19
Q

What is the purpose of BacSomatic in the testing apparatus?

A

Bacteria Counting and SCC Counting

BacSomatic is used for both counting bacteria and somatic cells.

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20
Q

What type of sample is Bacterial Control Sample (BCS)?

A

Control Sample

BCS is used as a standard to ensure the accuracy of the testing process.

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21
Q

Fill in the blank: All chemicals not provided by the manufacturer must be of _______ grade.

A

Analytical

This ensures the quality and reliability of the chemicals used in testing.

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22
Q

What is required for BacSomatic SCC Dye?

A

Lot number and Expiration Date

These details are crucial for traceability and quality control.

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23
Q

What are the sample ranges tested for the ESCC test?

A

100K-200K, 300K-500K, 600K-800K, 900K-1.2M

These ranges are specified for conducting the comparative test.

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24
Q

True or False: The results of the ESCC test can be used in the laboratory without evaluation.

A

False

Results must be evaluated and found acceptable prior to official use.

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25
Q

What are the components needed to prepare the Preservation Stock Solution for Bacterial Control Sample?

A

53 g Boric Acid, 0.8 g Potassium Sorbate, 10 g Glycerol

These components are mixed in a 2 L container.

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26
Q

How do you prepare the Preservation Stock Solution for Bacterial Control Sample?

A
  1. Add Boric Acid, Potassium Sorbate, and Glycerol to a 2 L container.
  2. Fill up to the 2000 mL mark with purified water.
  3. Stir until completely dissolved, heating to 40°C to speed up the process.
  4. Store at room temperature (< 25°C) for up to 10 weeks.

Ensure to use purified water as specified.

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27
Q

What is the shelf life of the Preservation Stock Solution for Bacterial Control Sample?

A

Up to 10 weeks at room temperature (< 25°C)

Proper storage conditions are crucial for maintaining solution efficacy.

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28
Q

What is the first step in preparing the Re-hydration Solution for Bacterial Control Sample?

A

Add one Ringer Tablet (Code BR 52) into a 1 L container

This is followed by adding purified water and Preservation Stock Solution.

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29
Q

What is the composition of the Re-hydration Solution for Bacterial Control Sample?

A

1 Ringer Tablet, 300 mL purified water, 200 mL Preservation Stock Solution

The mixture is stirred until completely dissolved.

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30
Q

What is the storage duration for the Re-hydration Solution?

A

Up to 7 days at room temperature (< 25°C)

After this period, the solution should not be used.

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31
Q

What is a Blank solution in this context?

A

Purified Water

It is used as a control in experiments.

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32
Q

What is the first step in preparing the Bacterial Control Sample (BCS)?

A

Measure 100 mL (* 2%) of purified water and transfer it to a suitable container with a lid

This step is critical for accurate dilution.

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33
Q

How should the Bacterial Control Sample vial be prepared for use?

A
  1. Remove the metal cap and loosen the lid.
  2. Transfer 2-3 mL of purified water into the vial.
  3. Close the vial and shake to dissolve.

This ensures the sample is ready for testing.

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34
Q

What is the time frame for using the Bacterial Control Sample after preparation?

A

Must be used within 1 hour

This is essential for maintaining sample integrity.

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35
Q

What is the first step when dissolving the Bacterial Control Sample?

A

Pour the contents of the vial into the container

Refer to item 10.b.1.a

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36
Q

What should be done with the pipette after pouring the Bacterial Control Sample?

A

Use the contents of the pipette to rinse the vial

Refer to item 10.b.1.b.4

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37
Q

What is the storage temperature range for the Bacterial Control Sample?

A

0.0-4.5°C

This is the temperature range for refrigeration.

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38
Q

How long can the re-constituted, preserved Bacterial Control Sample be stored in the refrigerator?

A

Up to 1 hour

Must be kept at 0.0-4.5°C

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39
Q

What is the maximum time the Bacterial Control Sample option 2 can be stored and used?

A

Must be used within 10 hours

This applies to the Ready to Use Bacterial Control Sample (BCS).

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40
Q

What volume of Re-hydration Solution is needed for the Bacterial Control Sample option 2?

A

100 mL (‡ 2%)

Refer to item 9.b.

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41
Q

What should be done after removing the metal cap from the Bacterial Control Sample vial?

A

Loosen the lid

This is necessary before adding the Re-hydration Solution.

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42
Q

How much Re-hydration Solution should be transferred into the Bacterial Control Sample vial?

A

2-3 mL

Use a small sterile, disposable 5 mL pipette.

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43
Q

What is the next step after closing the vial with the Re-hydration Solution?

A

Shake to completely dissolve

Ensure the sample is fully reconstituted.

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44
Q

What should be done with the contents of the vial after dissolving the Bacterial Control Sample?

A

Pour the contents into the container

Follow item 10.b.2.a.

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45
Q

What should be done after pouring the contents of the vial into the container?

A

Put the lid on and shake well

This ensures proper mixing.

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46
Q

How long can the re-constituted, preserved Bacterial Control Sample be stored when kept in the refrigerator?

A

Up to 10 hours

Must be kept at 0.0-4.5°C.

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47
Q

What is the volume of purified water to mix with ammonia for the End of Day Solution?

A

500 mL

Mix with 2.5 mL of 25% ammonia according to manufacturer’s User Manual.

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48
Q

What is the preparation ratio for the BacSomatic Rinse Solution?

A

10 mL of BacSomatic Rinse Concentrate with 5 L of purified water

Store and use within 1 week.

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49
Q

What should be included on all solution labels?

A

Solution name, date prepared, and expiration date

Include expiration date when relevant.

50
Q

How long can BacSomatic SCC Dye be used after insertion?

A

3 months

Insert according to manufacturer’s instructions.

51
Q

What are the ranges of the milk standards for DMSCC?

A

100K-200K, 300K-500K, 600K-800K, and 900K-1.2M

Four standards in each range.

52
Q

How should DMSCC be performed on milk standards?

A

In triplicate on each standard in set and average counts

Maintain records of the results.

53
Q

How often should DMSCC checks be performed?

A

In rotation by all certified analysts

Ensures reliability of results.

54
Q

What is the expiration timeframe for milk standards?

A

Used within one week

This applies to both commercially prepared and certified provider standards.

55
Q

What is the required storage for BacSomatic solutions?

A

Use within specific expiration dates

Expiration dates vary depending on the type of solution.

56
Q

Fill in the blank: The BacSomatic Rinse Solution must be used within _______.

A

1 week

After preparation.

57
Q

Fill in the blank: The BacSomatic SCC Dye must be used within _______.

A

3 months

After insertion.

58
Q

What should be maintained regarding DMSCC values?

A

Copies of all provided DMSCC values

59
Q

What temperature range should be recorded for standards upon receipt?

A

0.0-7.5°C

60
Q

What must be maintained concerning problems encountered?

A

Copies of all correspondence regarding problems

61
Q

What is the requirement for standards used by the manufacturer?

A

Used by manufacturer’s expiration date

62
Q

What should be done if standards fail?

A

Verify with DMSCC

63
Q

What is the first step if no analysts are certified for DMSCC?

A

A new set of standards is required

64
Q

What should not be done until new standards are tested in range?

A

Do not continue with official testing

65
Q

How often should laboratory prepared standards be made?

A

Weekly

66
Q

What is used to preserve raw milk for standards?

A

0.05% potassium dichromate (K2Cr207) or 0.02% 2-bromo-2-nitropropane-1,3-diol (Bronopol™)

67
Q

Which preservative cannot be used for standards?

A

Formalin

68
Q

What are the ranges for the four standards to be prepared?

A

100K-200K, 300K-500K, 600K-800K, 900K-1.2M

69
Q

Within how many weeks should the prepared standards be used?

A

One week

70
Q

What is required to be performed in triplicate on each standard?

A

DMSCC and average counts; maintain records

71
Q

Who should perform the DMSCC check?

A

All certified analysts

72
Q

What is the purpose of the hourly control sample?

A

Instrument drift check

73
Q

What range should be used for the hourly control sample?

A

600-800K range

74
Q

What should be checked daily at instrument start-up?

A

Volume of rinse/sheath liquid in supply containers

75
Q

How often must the rinse/sheath liquid be completely replaced?

A

Every 7 days or when volume is too low

76
Q

Fill in the blank: Standards cannot be preserved with _______.

A

formalin

77
Q

What should be done with solutions not used beyond expiration date(s)?

A

Solutions should not be used beyond expiration date(s)

This ensures the accuracy and reliability of test results.

78
Q

What mode must be activated on the instrument before measuring?

A

Measure mode

This prepares the instrument for accurate measurements.

79
Q

What is the first step in preparing the Bacterial Control Sample (BCS)?

A

Prepare Bacterial Control Sample (BCS) as the instrument goes into measure mode

This ensures the BCS is ready for testing alongside other measures.

80
Q

What is the acceptable mean SCC count during the blank check?

A

≤3,000 cells/mL

This is to ensure the baseline is within acceptable limits.

81
Q

What must individual measurements be below during the blank check?

A

<5,000 cells/mL

This ensures no significant contamination is present.

82
Q

What must all bacteria results be at or below during the blank check?

A

≤2 CFU

This indicates that the testing environment is free from bacterial contamination.

83
Q

What should be done if any quality check parameters are out of variance?

A

Correct before proceeding

Ensures that all measurements are valid and reliable.

84
Q

How many intakes should be run for the Bacterial Control Sample?

A

2 intakes

This helps ensure the reliability of the results.

85
Q

What must the Laboratory Average Count conform to?

A

Manufacturer Count Limits

This ensures compliance with manufacturer specifications.

86
Q

What must the Laboratory Average Signal Mean be within?

A

Manufacturer Provided Average Signal Mean

This is crucial for accurate measurement comparison.

87
Q

What should be done if the BCS sample is outside the specified limits?

A

Follow instructions in User Manual or seek technical assistance

This ensures proper troubleshooting and resolution.

88
Q

What is the first step for preparing the SCC standard?

A

Mix by inverting at least 25 times

This ensures homogeneity of the standard solution.

89
Q

How many of the 4 standards should be tested in triplicate for repeatability?

A

1 standard

This is to ensure reliable and repeatable measurements.

90
Q

What must the standard’s average be within for that level?

A

10% of the DMSCC

This is to ensure accuracy in the measurement standards.

91
Q

What is the acceptable percentage variance for the 100K-200K standard?

A

15%

This allows for a slightly wider margin of error at higher concentrations.

92
Q

What is the coefficient of variation (CV) requirement for a standard in the 300K to 800K range?

A

5% or less on 10 replicates

This requirement ensures the reliability of measurements in the specified range.

93
Q

What temperature range should samples be kept at until tested?

A

0.0-4.5°C

This temperature range helps to preserve the integrity of the samples.

94
Q

What should be done to samples before testing for bacteria?

A

Samples must first be tested for the presence of inhibitors

This step is crucial to ensure accurate bacteria testing results.

95
Q

How many times should a sample be inverted before testing?

A

No less than 25 times

Proper mixing is essential for representative sampling.

96
Q

What records must be maintained during testing?

A

Records of all results, controls, and samples

Maintaining accurate records is vital for traceability and quality assurance.

97
Q

What is the mean SCC count requirement during the blank check?

A

Must be ≤3,000 cells/mL

This ensures the instrument is functioning correctly before testing samples.

98
Q

What must be checked for the Bacterial Control Sample (BCS)?

A

Results must conform to specified limits

This step is essential for validating test accuracy.

99
Q

What is required for individual measurements during the blank check?

A

Individual measurements <5,000 cells/mL

Ensuring individual measurements stay below this threshold is important for quality control.

100
Q

What is the purpose of performing a quality check at the end of the day?

A

To ensure instrument reliability and accuracy

Regular quality checks help in maintaining the performance of laboratory equipment.

101
Q

What must be recorded for each sample during testing?

A

Number of somatic cells and bacteria counted

Accurate recording is crucial for data analysis and reporting.

102
Q

What is the significance of maintaining records on all parameters each time the instrument is used?

A

It ensures compliance and traceability

Detailed records facilitate audits and reviews of laboratory practices.

103
Q

What is the formula to calculate the cell count per mL of milk?

A

Count obtained x 1000

This formula is used for obtaining the Somatic Cell Count.

104
Q

When reporting electronic somatic cell counts (ESCC/mL), what digits should be recorded?

A

Only the first two left hand digits

The third digit affects rounding based on specific rules.

105
Q

What should be done if the BCS sample is outside specified limits?

A

Follow instructions in User Manual or seek technical assistance

This is crucial for maintaining accurate testing procedures.

106
Q

How should the second digit be rounded when reporting counts?

A
  • Odd: round up
  • Even: round down

This rounding method ensures accuracy in reporting.

107
Q

What is the required action for maintaining records?

A

Maintain records

This is essential for routine maintenance and compliance.

108
Q

What is the first step in preparing the SCC standard for testing?

A

Mix by inverting at least 25 times

Proper mixing ensures homogeneity of the sample.

109
Q

What should be done with the sample vial containing End of Day solution?

A

Place it under the pipette

This is part of the standard operating procedure for testing.

110
Q

What is the purpose of removing the waste funnel?

A

Clean sample collection funnel as described in User Manual

Regular cleaning is important for preventing contamination.

111
Q

What is the procedure for rounding the second digit when the third digit is 6 or more?

A

Raise the second digit to the next higher number

This rule applies specifically to the rounding of counts.

112
Q

What is the significance of the ‘Routine Maintenance’ section?

A

It outlines the necessary steps for maintaining accurate testing equipment

Following routine maintenance is critical for reliable results.

113
Q

What is reported when the count on the instrument is less than 100?

A

< 100,000 ESCC/mL

114
Q

What should be reported when samples contain inhibitors?

A

Positive for inhibitors or growth inhibitors (Gl)

115
Q

What is the unit for bacterial counting?

A

IBC (Individual Bacteria Counts)/uL

116
Q

How is IBC converted for reporting?

A

Using the conversion table entered into the instrument and reported as CFU/ML

117
Q

How is bacterial content reported for milk?

A

BacSomatic CFU/mL (CFU/uL x 1000 = CFU/mL)

118
Q

What must a laboratory analyst do for official reporting of CFU?

A

Convert CFU/uL to CFU/mL

119
Q

What digits are reported for bacterial content?

A

The two left hand digits (rounded)

120
Q

What rounding rule is applied if the third digit is 5?

A

Odd up, even down

121
Q

What happens when the second digit is odd during rounding?

A

Raise the second digit by 1

122
Q

What happens when the second digit is even during rounding?

A

Delete the 5 and report the second digit as is