QA Studio

February 2010

QA Studio: Raw Program - Antibiotics

"Industry shall screen all bulk milk pickup tankers... for Beta lactam drug residues". See Appendix N in the PMO.

QA Studio can help document the testing results and other details as required.

For more information on Beta Lactam test methods.

For more information on the general laboratory testing for antibiotics.

Latest Memoranda from the FDA. Recent updated 2400 forms.

Set up and Maintain Raw Defaults: In Raw Defaults > General Information tab > you can enter the different Industry Analysts and their corresponding number (Operator ID) as entered into the Reader (if applicable). The Industry Supervisor can also be entered and this information will show up on the antibiotic reports. There are more items that can be set up and are as follows:

1. Raw Defaults (tab 1): Go to Raw Defaults > Antibiotic 1 tab > Enter the Beta Lactam Test Type, Kit Lot #, and Expiration Date. Enter the Positive Lot #, Expiration Date, Manufacturer and Date Received. Information can also be added for other drug testing (if applicable). If not applicable, you can check the box to the right and hide the other drug details in the Raw Program Product window. Enter the Negative and Positive Control range as well as the Negative and Positive test result range. Enter the Calibration Strip range as indicted on the strips.

Raw Defaults - Tab 1

2. Raw Defaults (tab 2): Go to Raw Defaults > Antibiotic 2 tab > Enter the Sample temperature, the Heat Block temperature and the second Heat Block temperature (if applicable), and the Refrigerator temperature (OC to 4.4C). You also have the ability to rename the Retest 1 and Retest 2 fields. For example: you can rename to Duplicate 1 and Duplicate 2. You can also select OP Code is REC Init. This will auto fill the Operator Code with the receiver's initials if the receiver is the person completing the antibiotic test.

Raw Defaults - Antibiotic 2

3. Raw Defaults (Reports tab): Go to Raw Defaults > Reports tab > Select if you would like to include the Daily Antibiotic checks on the Daily Antibiotic Report. If you would like to enter information on the Antibiotic Report footer, enter in the field on the right under "Antibiotic / IA Report Footer".

Raw Defaults - Reports tab

4. Raw Defaults (Data Entry tab): Go to the Raw Defaults > Data Entry Defaults tab > you can enter the amount of time it takes to perform the antibiotic test. For example: if the antibiotic test takes 8 minutes, you can enter (or import) the data from the printer, and the start time will be auto-calculated 8 minutes prior to the test finish time.

Raw Defaults - Data Entry Defaults tab

Daily Antibiotic Check Window: The daily performance checks that are performed on the test equipment and test kits can be documented in QA Studio. Go to Raw Program menu > Daily Antibiotic Check window > click Add and enter the testing details. The lot numbers and test kit information will auto-fill from the information set up in the defaults (it is very important to maintain the defaults with the proper information). Information can be changed in the Daily Antibiotic window if needed. The data can be imported where applicable (clicking on the small icon on the far left under "Charm Op").

Daily Antibiotic Window

 

Refrigerator Checks: When performing a PM temperature check for the refrigerator, you can find the information entered earlier that same day in the Raw Antibiotic Check window > click Edit > enter the PM refrigerator check including time and temperature into the corresponding fields. It is best not to start a whole new record but simply add to the information already entered that day. Then you can go to the AB Report menu at the bottom right hand corner and have a refrigerator report with the AM and PM refrigerator check for each day.

PM Refrigerator Check

Refrigerator Report

 

Entering Antibiotic Results: As you test the raw milk tankers for antibiotics, you can click on the Receiving Tests tab and enter the testing results. If applicable at your facility, the import button can be clicked (button below OP Code) and results will be imported. Note: temperatures will need to be added since reader results don't include temperatures. Also, note that the lot number will auto-fill from the lot number set up in the defaults. It can be changed if needed.

Entering data on Receiving Tests tab

 

Antibiotic Report: Click FIND, enter the date range and the product. For example: Quick Date "Yesterday" Product: "RawTankers" then go to Raw Program menu > Raw Reports > Antibiotic Reports > From the List > Standard (or select another report) > Print. The report will have the checks run right before the first tanker (if selected to show on report), and the footer will be included (if applicable). The tester print out can be stapled to the report and filed for easy review by the LEO.

Antibiotic Report

Performance checks can be included on each Daily Antibiotic report as seen above. Or you can print all the checks together without the results by going to Daily Antibiotic Check window > Find the data (click the icon with the magnifying glass) > enter the data range > OK. Then go to the AB reports at the bottom of the Daily Antibiotic Check window > Standard Report.

Did you know...If you go to Raw Defaults > General Information > Day Starts at field. You can set the time your receiving day typically starts. For example: if you receive raw milk tankers from 7:00am to 12:00am. You can enter 7:00am. Then if a tanker is behind schedule and arrives late at 2:00am, the data will go with the right receiving date when you find the data. The FIND on Yesterday, Today, 2 days ago and 3 days ago will find from 7:00am to 6:59am. So finding yesterday raw milk tankers will find tankers from 7:00am to 6:59am instead of midnight to midnight. The late tanker will go with the correct receiving day from the previous day instead of being grouped with the next day samples since it is past midnight.

07:00 to 06:59

Did you know...You can find the positive antibiotics for a given time period. For example: Find > Quick Dates "This Year" Beta L "POS" > OK.

Find Positive Antibiotics for a given time period

Did you know...You can test the incoming new antibiotic kit lot number when they arrive and enter the results into the Raw Daily Antibiotic Check window. You can then click the New Lot Number to indicate this is a new lot number test. You can then run a New Lot Performance Report. Daily Antibiotic Check Window > AB Reports > New Lot Review Report.

Indicate if a new lot number being testedNew Lot Number Report

Did you know...You can enter the negative test results in the Raw Daily Antibiotic window and the source where the negative control was obtained. You can then run a Negative Suitability Report. Daily Antibiotic Check Window > AB Reports > Suitability Report.

Negative Control DetailsNegative Suitability Report

If you have any questions or requests to add to QA Studio to enhance the Antibiotic data entry, documentation or reports, please feel free to contact us at support@qastudio.com

Benefit to QA Studio User: QA Studio can retain your antibiotic results in an organized manner, you can print reports and summaries and retrieve information easily.

 

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