Fossomatic Bacsomatic Flashcards
What does FOSSOMATIC BACSOMATIC ™ analyze?
Raw Commingled Cow Milk
This is the primary focus of the FOSSOMATIC BACSOMATIC ™ testing system.
What are the IMS numbers associated with FOSSOMATIC BACSOMATIC ™?
7e & 16h
These numbers indicate specific standards or requirements for the system.
What is the tolerance level mentioned in the document?
$5%
This tolerance applies unless otherwise stated in the document.
What are the sample requirements for raw milk testing?
See CP items 33 & 34
Specific guidelines for handling and testing raw milk samples.
How long can un-preserved raw milk samples be run for bacteria counting after collection?
Up to 60 hours
This is the time frame for testing raw milk for bacteria without preservation.
What is the maximum time frame for SCC counting with un-preserved samples?
Up to 72 hours
This refers to somatic cell count testing.
How long can preserved samples be tested for SCC counting?
Up to 7 days
Preserved with 0.02% 2-bromo-2-nitropropane-1,3-diol or 0.05% potassium dichromate.
What is required for simultaneous bacteria and SCC counting?
Criteria for bacteria counting apply
This means the same conditions for bacteria counting also apply to SCC.
What is a prerequisite for testing with the Standard Plate Count?
Comparative Test with Standard Plate Count with Approved Media
This involves testing 25 samples in duplicate.
How many samples should be tested in duplicate for the comparative test?
25 samples
This is required for accurate comparison using the SPC or PAC methods.
Who must perform the comparisons for the tests?
Certified analysts
Analysts must be certified for SPC or PAC methods.
What must be included in the QC records regarding test comparisons?
Copy of comparisons and results
These should be easily accessible in the laboratory.
Is a Comparative Test with DMSCC required for certification of analysts?
No, if purchasing standards from a certified provider
This indicates a specific exemption in the certification process.
Who must be certified for DMSCC?
Analyst(s)
Certification is mandatory for those performing DMSCC.
What is the first step each analyst must perform for the ESCC test?
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.
Who must evaluate the results of the ESCC test?
FDA/LPET LEO or LEO
Results must be shown to be acceptable prior to official use of the test in the laboratory.
What must be kept in the QC record regarding the ESCC test?
Copy of comparison and results
This must be kept for as long as the analyst is certified.
What is the conductivity requirement for deionized water used in the test?
Less than 2uS/cm
This is specified in CP item 24.c.3.
What is the purpose of BacSomatic in the testing apparatus?
Bacteria Counting and SCC Counting
BacSomatic is used for both counting bacteria and somatic cells.
What type of sample is Bacterial Control Sample (BCS)?
Control Sample
BCS is used as a standard to ensure the accuracy of the testing process.
Fill in the blank: All chemicals not provided by the manufacturer must be of _______ grade.
Analytical
This ensures the quality and reliability of the chemicals used in testing.
What is required for BacSomatic SCC Dye?
Lot number and Expiration Date
These details are crucial for traceability and quality control.
What are the sample ranges tested for the ESCC test?
100K-200K, 300K-500K, 600K-800K, 900K-1.2M
These ranges are specified for conducting the comparative test.
True or False: The results of the ESCC test can be used in the laboratory without evaluation.
False
Results must be evaluated and found acceptable prior to official use.
What are the components needed to prepare the Preservation Stock Solution for Bacterial Control Sample?
53 g Boric Acid, 0.8 g Potassium Sorbate, 10 g Glycerol
These components are mixed in a 2 L container.
How do you prepare the Preservation Stock Solution for Bacterial Control Sample?
- Add Boric Acid, Potassium Sorbate, and Glycerol to a 2 L container.
- Fill up to the 2000 mL mark with purified water.
- Stir until completely dissolved, heating to 40°C to speed up the process.
- Store at room temperature (< 25°C) for up to 10 weeks.
Ensure to use purified water as specified.
What is the shelf life of the Preservation Stock Solution for Bacterial Control Sample?
Up to 10 weeks at room temperature (< 25°C)
Proper storage conditions are crucial for maintaining solution efficacy.
What is the first step in preparing the Re-hydration Solution for Bacterial Control Sample?
Add one Ringer Tablet (Code BR 52) into a 1 L container
This is followed by adding purified water and Preservation Stock Solution.
What is the composition of the Re-hydration Solution for Bacterial Control Sample?
1 Ringer Tablet, 300 mL purified water, 200 mL Preservation Stock Solution
The mixture is stirred until completely dissolved.
What is the storage duration for the Re-hydration Solution?
Up to 7 days at room temperature (< 25°C)
After this period, the solution should not be used.
What is a Blank solution in this context?
Purified Water
It is used as a control in experiments.
What is the first step in preparing the Bacterial Control Sample (BCS)?
Measure 100 mL (* 2%) of purified water and transfer it to a suitable container with a lid
This step is critical for accurate dilution.
How should the Bacterial Control Sample vial be prepared for use?
- Remove the metal cap and loosen the lid.
- Transfer 2-3 mL of purified water into the vial.
- Close the vial and shake to dissolve.
This ensures the sample is ready for testing.
What is the time frame for using the Bacterial Control Sample after preparation?
Must be used within 1 hour
This is essential for maintaining sample integrity.
What is the first step when dissolving the Bacterial Control Sample?
Pour the contents of the vial into the container
Refer to item 10.b.1.a
What should be done with the pipette after pouring the Bacterial Control Sample?
Use the contents of the pipette to rinse the vial
Refer to item 10.b.1.b.4
What is the storage temperature range for the Bacterial Control Sample?
0.0-4.5°C
This is the temperature range for refrigeration.
How long can the re-constituted, preserved Bacterial Control Sample be stored in the refrigerator?
Up to 1 hour
Must be kept at 0.0-4.5°C
What is the maximum time the Bacterial Control Sample option 2 can be stored and used?
Must be used within 10 hours
This applies to the Ready to Use Bacterial Control Sample (BCS).
What volume of Re-hydration Solution is needed for the Bacterial Control Sample option 2?
100 mL (‡ 2%)
Refer to item 9.b.
What should be done after removing the metal cap from the Bacterial Control Sample vial?
Loosen the lid
This is necessary before adding the Re-hydration Solution.
How much Re-hydration Solution should be transferred into the Bacterial Control Sample vial?
2-3 mL
Use a small sterile, disposable 5 mL pipette.
What is the next step after closing the vial with the Re-hydration Solution?
Shake to completely dissolve
Ensure the sample is fully reconstituted.
What should be done with the contents of the vial after dissolving the Bacterial Control Sample?
Pour the contents into the container
Follow item 10.b.2.a.
What should be done after pouring the contents of the vial into the container?
Put the lid on and shake well
This ensures proper mixing.
How long can the re-constituted, preserved Bacterial Control Sample be stored when kept in the refrigerator?
Up to 10 hours
Must be kept at 0.0-4.5°C.
What is the volume of purified water to mix with ammonia for the End of Day Solution?
500 mL
Mix with 2.5 mL of 25% ammonia according to manufacturer’s User Manual.
What is the preparation ratio for the BacSomatic Rinse Solution?
10 mL of BacSomatic Rinse Concentrate with 5 L of purified water
Store and use within 1 week.
What should be included on all solution labels?
Solution name, date prepared, and expiration date
Include expiration date when relevant.
How long can BacSomatic SCC Dye be used after insertion?
3 months
Insert according to manufacturer’s instructions.
What are the ranges of the milk standards for DMSCC?
100K-200K, 300K-500K, 600K-800K, and 900K-1.2M
Four standards in each range.
How should DMSCC be performed on milk standards?
In triplicate on each standard in set and average counts
Maintain records of the results.
How often should DMSCC checks be performed?
In rotation by all certified analysts
Ensures reliability of results.
What is the expiration timeframe for milk standards?
Used within one week
This applies to both commercially prepared and certified provider standards.
What is the required storage for BacSomatic solutions?
Use within specific expiration dates
Expiration dates vary depending on the type of solution.
Fill in the blank: The BacSomatic Rinse Solution must be used within _______.
1 week
After preparation.
Fill in the blank: The BacSomatic SCC Dye must be used within _______.
3 months
After insertion.
What should be maintained regarding DMSCC values?
Copies of all provided DMSCC values
What temperature range should be recorded for standards upon receipt?
0.0-7.5°C
What must be maintained concerning problems encountered?
Copies of all correspondence regarding problems
What is the requirement for standards used by the manufacturer?
Used by manufacturer’s expiration date
What should be done if standards fail?
Verify with DMSCC
What is the first step if no analysts are certified for DMSCC?
A new set of standards is required
What should not be done until new standards are tested in range?
Do not continue with official testing
How often should laboratory prepared standards be made?
Weekly
What is used to preserve raw milk for standards?
0.05% potassium dichromate (K2Cr207) or 0.02% 2-bromo-2-nitropropane-1,3-diol (Bronopol™)
Which preservative cannot be used for standards?
Formalin
What are the ranges for the four standards to be prepared?
100K-200K, 300K-500K, 600K-800K, 900K-1.2M
Within how many weeks should the prepared standards be used?
One week
What is required to be performed in triplicate on each standard?
DMSCC and average counts; maintain records
Who should perform the DMSCC check?
All certified analysts
What is the purpose of the hourly control sample?
Instrument drift check
What range should be used for the hourly control sample?
600-800K range
What should be checked daily at instrument start-up?
Volume of rinse/sheath liquid in supply containers
How often must the rinse/sheath liquid be completely replaced?
Every 7 days or when volume is too low
Fill in the blank: Standards cannot be preserved with _______.
formalin
What should be done with solutions not used beyond expiration date(s)?
Solutions should not be used beyond expiration date(s)
This ensures the accuracy and reliability of test results.
What mode must be activated on the instrument before measuring?
Measure mode
This prepares the instrument for accurate measurements.
What is the first step in preparing the Bacterial Control Sample (BCS)?
Prepare Bacterial Control Sample (BCS) as the instrument goes into measure mode
This ensures the BCS is ready for testing alongside other measures.
What is the acceptable mean SCC count during the blank check?
≤3,000 cells/mL
This is to ensure the baseline is within acceptable limits.
What must individual measurements be below during the blank check?
<5,000 cells/mL
This ensures no significant contamination is present.
What must all bacteria results be at or below during the blank check?
≤2 CFU
This indicates that the testing environment is free from bacterial contamination.
What should be done if any quality check parameters are out of variance?
Correct before proceeding
Ensures that all measurements are valid and reliable.
How many intakes should be run for the Bacterial Control Sample?
2 intakes
This helps ensure the reliability of the results.
What must the Laboratory Average Count conform to?
Manufacturer Count Limits
This ensures compliance with manufacturer specifications.
What must the Laboratory Average Signal Mean be within?
Manufacturer Provided Average Signal Mean
This is crucial for accurate measurement comparison.
What should be done if the BCS sample is outside the specified limits?
Follow instructions in User Manual or seek technical assistance
This ensures proper troubleshooting and resolution.
What is the first step for preparing the SCC standard?
Mix by inverting at least 25 times
This ensures homogeneity of the standard solution.
How many of the 4 standards should be tested in triplicate for repeatability?
1 standard
This is to ensure reliable and repeatable measurements.
What must the standard’s average be within for that level?
10% of the DMSCC
This is to ensure accuracy in the measurement standards.
What is the acceptable percentage variance for the 100K-200K standard?
15%
This allows for a slightly wider margin of error at higher concentrations.
What is the coefficient of variation (CV) requirement for a standard in the 300K to 800K range?
5% or less on 10 replicates
This requirement ensures the reliability of measurements in the specified range.
What temperature range should samples be kept at until tested?
0.0-4.5°C
This temperature range helps to preserve the integrity of the samples.
What should be done to samples before testing for bacteria?
Samples must first be tested for the presence of inhibitors
This step is crucial to ensure accurate bacteria testing results.
How many times should a sample be inverted before testing?
No less than 25 times
Proper mixing is essential for representative sampling.
What records must be maintained during testing?
Records of all results, controls, and samples
Maintaining accurate records is vital for traceability and quality assurance.
What is the mean SCC count requirement during the blank check?
Must be ≤3,000 cells/mL
This ensures the instrument is functioning correctly before testing samples.
What must be checked for the Bacterial Control Sample (BCS)?
Results must conform to specified limits
This step is essential for validating test accuracy.
What is required for individual measurements during the blank check?
Individual measurements <5,000 cells/mL
Ensuring individual measurements stay below this threshold is important for quality control.
What is the purpose of performing a quality check at the end of the day?
To ensure instrument reliability and accuracy
Regular quality checks help in maintaining the performance of laboratory equipment.
What must be recorded for each sample during testing?
Number of somatic cells and bacteria counted
Accurate recording is crucial for data analysis and reporting.
What is the significance of maintaining records on all parameters each time the instrument is used?
It ensures compliance and traceability
Detailed records facilitate audits and reviews of laboratory practices.
What is the formula to calculate the cell count per mL of milk?
Count obtained x 1000
This formula is used for obtaining the Somatic Cell Count.
When reporting electronic somatic cell counts (ESCC/mL), what digits should be recorded?
Only the first two left hand digits
The third digit affects rounding based on specific rules.
What should be done if the BCS sample is outside specified limits?
Follow instructions in User Manual or seek technical assistance
This is crucial for maintaining accurate testing procedures.
How should the second digit be rounded when reporting counts?
- Odd: round up
- Even: round down
This rounding method ensures accuracy in reporting.
What is the required action for maintaining records?
Maintain records
This is essential for routine maintenance and compliance.
What is the first step in preparing the SCC standard for testing?
Mix by inverting at least 25 times
Proper mixing ensures homogeneity of the sample.
What should be done with the sample vial containing End of Day solution?
Place it under the pipette
This is part of the standard operating procedure for testing.
What is the purpose of removing the waste funnel?
Clean sample collection funnel as described in User Manual
Regular cleaning is important for preventing contamination.
What is the procedure for rounding the second digit when the third digit is 6 or more?
Raise the second digit to the next higher number
This rule applies specifically to the rounding of counts.
What is the significance of the ‘Routine Maintenance’ section?
It outlines the necessary steps for maintaining accurate testing equipment
Following routine maintenance is critical for reliable results.
What is reported when the count on the instrument is less than 100?
< 100,000 ESCC/mL
What should be reported when samples contain inhibitors?
Positive for inhibitors or growth inhibitors (Gl)
What is the unit for bacterial counting?
IBC (Individual Bacteria Counts)/uL
How is IBC converted for reporting?
Using the conversion table entered into the instrument and reported as CFU/ML
How is bacterial content reported for milk?
BacSomatic CFU/mL (CFU/uL x 1000 = CFU/mL)
What must a laboratory analyst do for official reporting of CFU?
Convert CFU/uL to CFU/mL
What digits are reported for bacterial content?
The two left hand digits (rounded)
What rounding rule is applied if the third digit is 5?
Odd up, even down
What happens when the second digit is odd during rounding?
Raise the second digit by 1
What happens when the second digit is even during rounding?
Delete the 5 and report the second digit as is
