I. PURPOSE

This directive instructs inspection program personnel (IPP) and other Agency personnel how to access Laboratory Information System-Direct (LIMS-Direct) to view reportable FSIS laboratory sample status and testing results.

II. CANCELLATION

FSIS Directive 10,200.1, Accessing Laboratory Sample Information via LEARN, 7/19/01

III. BACKGROUND

A. LIMS-Direct is a reporting interface that displays FSIS lab sample results directly from LIMS. It provides sample status and analysis result information for samples submitted to FSIS laboratories. Data are updated every 15 minutes and LIMS-Direct provides sample data electronically to Agency personnel, federal establishments (if a valid e-mail address has been entered into the PHIS establishment profile), State officials, and State-inspected establishments (if FSIS laboratories conduct testing for the State).

B. Through the LIMS-Direct interface, users can:

1. Search sample data reported from June 14, 2010, to the present (the default search date is 90 days prior to current date);
2. Save any sample report as a PDF file;
3. Sort data using designated column headings to better locate and track samples; and
4. Search data using a date range.

IV. ACCESSING LIMS – DIRECT

A. The LIMS-Direct User Guide (posted on the FSIS webpage with this directive as a related document) provides step-by-step instructions for using LIMS-Direct to view results and generate reports for samples submitted to the FSIS Laboratories.

B. IPP and users with level 2 eAuthentication can access LIMS-Direct on their FSIS computers by clicking on the Start menu à FSIS Applications à Internet-Intranet à LIMS-Direct. IPP can also access LIMS- Direct through the Public Health Information System (PHIS) when reviewing individual sample results on the PHIS Homepage. Establishment personnel do not have access to LIMS-Direct to view test results but can request to receive test results reported through LIMS-Direct via e-mail, as described in Section V.C.

NOTE: IPP can access FSIS test results directly on the PHIS Establishment homepage under Laboratory Sampling. It is not mandatory that IPP use LIMS-Direct to view test results. However, IPP can obtain additional test result information by clicking on the LIMS-Direct link available in the Lab Result Report.

V. RESULT REPORTING THROUGH LIMS-DIRECT

A. LIMS-Direct reports information specific to each sample submitted for analysis, including:

1. Collection date;
2. Sample collection form number;
3. LIMS sample number;
4. Whether product is held, as specified in the sample form;
5. Status of analysis;
6. Reportable results; and
7. Date of last update.

NOTE: Sample collection information displayed in LIMS-Direct comes directly from PHIS. Any errors in this information need to be corrected in the PHIS sample collection record.

B. FSIS positive test results are communicated via Alerts in PHIS on the Inspector’s Homepage. All FSIS sample result information is accessible through the Establishment Profile Summary page in the Laboratory Sampling panel and through the Dashboard on the Inspector homepage.

C. An establishment can request to receive FSIS sample results by e-mail. IPP are to refer to FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System (PHIS), for instructions on how to update the establishment's contact information to include an e-mail address for receiving FSIS lab sample results. IPP may designate up to three establishment personnel as an “FSIS Lab Sampling Result Contact” in the PHIS establishment profile to receive sample results by e-mail.

VI. IPP RESPONSIBILITIES UPON RECEIVING TEST RESULTS

IPP are to regularly check the status of test results through PHIS. In accordance with FSIS policy, once final test results are reported IPP are to review them, notify the establishment of the test results and take any necessary action based on those results. IPP are to refer to the appropriate FSIS Notice or Directive for instructions on actions to take based upon the reported test results for the specific sampling project.

NOTE: IPP are only to release FSIS sample results to the establishment from which the sample was collected.

VII. QUESTIONS

Refer questions regarding this Directive to the Risk, Innovations, and Management Staff through askFSIS or by telephone at 1-800-233-3935. When submitting a question, use the Submit a Question tab, and enter the following information in the fields provided:

Subject Field:       Enter Directive 10,210.5
Question Field:    Enter question with as much detail as possible.
Product Field:      Select General Inspection Policy from the drop-down menu.
Category Field:  Select Sampling – General.
Policy Arena:       Select Domestic (U.S.) Only from the drop-down menu.

When all fields are complete, press Continue and, at the next screen, press Finish Submitting Question.

NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.