Download:
pdf |
pdfOMB Number: 0910-0909 Exp Date: XX/XX/XXXX
See bottom of page 7 for PRA statement
Micro LFFM Human & Animal Food State Surveillance Data Entry Instructions
Quarterly Surveillance Data Spreadsheet
Contents
At the Beginning of the Budget Period
Throughout the Budget Period
Submitting your Data
Troubleshooting:
Important:
1
2
3
6
6
At the Beginning of the Budget Period
1.
2.
a.
b.
c.
Enter the activation workgroup “LFFM M‐HAF Product Testing Track Quarterly Reporting”
Download the surveillance template from Lab Data Entry portion of the workgroup.
Click “Enter Lab Data”
Click “Get Blank Data Spreadsheet Template”
Open with Excel
3. Save the template in your files without changing any rows, columns or cells in the spreadsheet. You can enable
editing. This will serve as the document that you will use to track your surveillance data.
Throughout the Budget Period
4. Record surveillance data throughout the budget period in the spreadsheet without changing anything about the
template including column headers, sizes, blank areas, row heights, etc.
a. Columns A‐P are required to be filled out for each sample (see exception for column G, below). If you do not have
the information for those columns you can write “unknown”.
i. Recording ‘unknown’ is not appropriate for all fields.
1. For example – If an expiration date is not listed on the label, it is okay to record ‘unknown’ in this field. It is not
appropriate to record ‘unknown’ for manufacturer/brand, or collection date, or other key identifying information
about the sample.
ii. For human food samples, record “N/A – Human Food” in column F, and then column G can
be left blank
b.
SPECIAL NOTES – IMPORTANT:
i. If your lab chose to use LFFM funds to do Cronobacter testing for the recent event in
Infant Formula, please report all LFFM funded Cronobacter samples. As there is no column for Cronobacter in the
reporting template, please use the "Other Analyte" Column and write in "Cronobacter sakazakii" (NOTE: This is not an
option in the drop down menu and must be typed in).
ii. Commodity Category (Assigned) – Column E – this MUST be the commodity category
selected for your sample‐product must match the assigned commodity/hazard pair category that was on your
approved Sampling Plan
1. Special note – if your laboratory participated in the FDA 3rd party (IEH) cereal assignment, record your samples
against the category “RTE packaged/boxed cereals & granolas (not bulk)”, even if it was not on your current budget
period's approved sampling plan. In Comments (very last field), record “FDA 3rd Party Cereal Assignment”. Record
samples that were analyzed during the LFFM budget period/reporting period.
iii. Country of Origin – this it is the country of the manufacturer/processor (responsible firm).
Examples:
1.
Enoki mushrooms, says ‘distributed by’ a US company, product of China – record China as country of origin
2. Cashews, says ‘packed/processed by’ a US company, and on label lists ‘contains cashews from vietnam, brazil,
ivory coast’ – record US as country of origin
3.
Identity of firm that produced the product unclear – record ‘unknown’ for country of origin
iv. Collecting Entity – Column M
1.
If collected by laboratory analysts, write “Laboratory”
2. If collected by a regulatory program, write the Agency name and the program name – E.g., State Department of
Agriculture, Food Safety Division
3. Special note – if your laboratory participated in the FDA 3rd party (IEH) cereal assignment, enter “IEH – FDA 3rd
Party Cereal Assignment”
1.
v. Analyte fields: Screen, Confirmatory, Final
Screen Result values:
a.
CRO – Cannot Rule Out – please select if a screen was performed and the result was detected
b.
ND – Not Detected – please select if a screen was performed and the result was not detected
c.
N/A – Not Performed – please select if you were testing for the analyte, but did not perform a screening test
2. Confirmatory Result values:
a. Salmonella spp. (or other analyte) Found – please select if a confirmatory test was performed and the result was
detected
b. No Salmonella spp. (or other analyte) Found – please select if a confirmatory test was performed and the result
was not detected
c. N/A – Not Performed – please select if you were testing for the analyte, but did not perform a confirmatory test
(e.g., because the screen was not detected)
3. Final Result values
a. Salmonella spp. (or other analyte) Found – please select if the confirmatory test showed that the target analyte
was detected
b. Negative – please select if a screen test showed the target analyte was not detected (no confirmatory test
performed), or a confirmatory test showed the target analyte was not detected.
vi. Salmonella Serotype – Column U – for poultry feed samples positive for Salmonella only,
please enter the Salmonella serotype
vii. Comments – Column BG – for positive samples, please include any details re: state action
taken on the sample results – embargo, recall, consumer advisory, etc.
c. Leave testing columns blank if you did not perform that testing.
i. Do not put N/A in columns/fields for analytes you didn’t test for. For example – Tomatoes
analyzed for Salmonella: N/A in Confirmatory test has meaning (confirmatory test was not performed, screen was Not
Detected); do not put N/A in the Listeria, Campy, Cyclo analysis fields – leave them blank.
d. Leave Turn‐Around‐Time columns blank – we will fill them out later using a formula (NETWORKDAYS ‐ number of
work days between the time you finished analysis and the time you started the analysis, will also remove federal
holidays from the calculation).
e.
Please check all dates for typos (correct budget periods) before submitting
5. FDA ORS will coordinate when your surveillance data should be uploaded to the data entry section. This will
happen on a quarterly basis and should not be done until prompted. NOTE: Any sample testing resulting in a CRO or
confirmed positive must be communicated immediately to the LFFM Inbox and HAF Division Inbox and cannot wait
until the quarterly upload.
Submitting your Data
How the FERN Activation Data Entry Module Works
When you upload a new spreadsheet (dataset), the system looks at the Sample ID field and compares it to the data
already in the system that your lab submitted.
If the sample ID is new, then it adds the new record
If the sample ID is the same as another sample previously submitted, then it updates the data for that sample
(overwrites it)
When submitting data in Q2‐4, we recommend that you only submit the new quarter’s samples (so you are only
submitting new sample IDs to the system). However, we don’t want to be burdensome, so if it is easier for you to have
a single spreadsheet with the entire Budget period’s samples and upload it at each quarter, that is acceptable.
If you opt to have a single spreadsheet (including all samples from the budget period) that you upload every
quarter, please be aware that every time you submit data, you are overwriting data from a prior quarter (same sample
IDs). This becomes important if ORS asked you to update or fix data elements during a prior quarters’ data review. You
must make sure those edits are reflected in both the FERNlab.org activation portal and your locally saved data
spreadsheet, otherwise when you submit data in a future quarter, the fixed data elements will revert back to their
prior state and need to be cleaned/updated again.
When you are ready to upload your surveillance data to the activation workgroup follow these instructions:
6.
Go the activation workgroup and select “Enter Lab Data”
7.
8.
9.
Click on “Get Blank Data Spreadsheet Template”
Open it with Microsoft Excel
Click on Enable Editing
10. Without changing anything about the blank data spreadsheet, copy and paste just the surveillance data from the
template you had saved in your records. It works best if you only highlight the entire section of data instead of
selecting entire rows. NOTE: You can attempt to skip steps 2‐5 and just upload the spreadsheet you have in your
files, but we find that starting fresh with a new template prevents errors.
11. Once your quarterly data is populated into the blank data spreadsheet template, save it to your desktop or in your
files, keeping the same name as what was given by the system (it may save as “copy of…” which is fine)
12. Click “Enter Lab Sample Data”
13. Click “Upload Spreadsheet”
14. Click “Select Files”. Find the document you just saved and click “Open”
15. When the document is done processing ‐ Click Next. The system will check to see if your spreadsheet match
16. The data you copied should show in the data entry module on the screen. Check to be sure all your data was
uploaded and then click “save data”. If you forget to click save you will lose your data.
17. After your data is saved you can add rows to manually add more data, delete rows that had errors etc.
Troubleshooting:
The majority of data upload errors are because of changes to the spreadsheet template, blank rows, formatting
changes, etc. If you receive an error message, please follow the instructions exactly and only copy and paste the cells
with data into the downloaded template without selecting entire rows and columns. If you still experience issues
reach out to your FDA technical lead(s).
Important:
This workgroup is used to track your state collected and state analyzed surveillance data. Any other data for other
tracks or associated with FDA assignments or actual activations should be entered into the activations set up for that
purpose and should not be double‐entered in this activation workgroup. If you have questions reach out to your FDA
technical lead(s).
For the current budget period ‐ if your laboratory participated in the FDA 3rd party (IEH) cereal assignment, record
your samples against the category “RTE packaged/boxed cereals & granolas (not bulk)”, even if it was not on your
current budget period's approved sampling plan. In Comments (very last field), record “FDA 3rd Party Cereal
Assignment”. Record samples that were analyzed during the LFFM budget period/reporting period (7/1 or later).
For the current budget period ‐ If your lab chose to use LFFM funds to do Cronobacter testing for the recent event
in Infant Formula, please report all LFFM funded Cronobacter samples. As there is no column for Cronobacter in the
reporting template, please use the "Other Analyte" Column and write in "Cronobacter sakazakii" (NOTE: This is not an
option in the drop down menu and must be typed in).
Change History
1/27/22 – clarified that calculation of turnaround time is done based on net work days (including federal holidays)
2/8/22 – added examples of how to interpret and record Country of Origin
4/4/22 – added information on how to report Cronobacter testing
File Type | application/pdf |
File Title | LFFM QTR LFFM Data Template Micro HAF Product Testing.xlsx |
Author | Jolene.Gordon |
File Modified | 2023-12-05 |
File Created | 2022-07-10 |