1. Reasons for Correcting Test Results
A correction or amendment of test results may become necessary for various reasons:
- Analytical errors: errors in the testing system or reagent usage discovered after the fact.
- Pre-analytical errors: for example, a mix-up of sample identifiers or incorrect assignment of the sample to a submitter or animal.
- Supplementary testing: requests for additional parameters from the same sample—for instance, an antibiogram following a positive bacteriological result.
- Transmission errors: manual data entry or transfer errors.
- Incorrect information provided by the submitter: inaccurate or incomplete patient details, such as species, age, name, vaccination status, or identification number.
2. Amendment Process
-
2.1 Recording and Root Cause Analysis
If a test result is suspected to be erroneous, a sample-specific complaint record is created in our database (DDB). This record documents, among other things, the nature of the potential error, communication with the submitter, and the findings of the root cause analysis.
The affected result is locked in the database until the necessary corrective actions are completed. This prevents the potential use of an erroneous result without prior verification.
-
2.2 Classification and Risk Assessment
The potential error is classified based on its nature and impact. The classification determines the information and corrective actions required.
Severity Submitter notification and correction Category 4 – Critical error Immediately, by telephone and/or email Category 3 – Serious error By email, as soon as possible Category 2 – Non-critical error Correction in writing; prior notification by telephone not required Category 1 – No laboratory error Generally correctable if the validity of the test result is not compromised; assessed case by case where specific patient identification requirements apply, e.g. for travel purposes Category 4 – Critical error
A critical error occurs when the error alters the diagnostic conclusion or could have a significant impact on further patient-related actions—for example, in cases of sample mix-ups or erroneous reporting.
Actions:
The submitter (veterinarian) is informed immediately by telephone and/or email so that any potential impact on the patient can be minimized as quickly as possible. The contact details—including date, time, and the person spoken to—are documented in the complaint record. Furthermore, the root causes are investigated, and necessary corrective actions are initiated.
Category 3 – Serious error
This category includes errors that do not have an immediate impact on the patient, such as an incorrect test or a test that was inadvertently not performed.
Actions:
The submitter is informed of the incident via email as soon as possible. The requested test is performed and reported, provided this is necessary and feasible. Depending on the cause, further investigation of the incident and corrective actions are initiated.
Category 2 – Non-critical error
This category covers errors that do not affect the medical interpretation of the test result, such as typos in the animal owner's name or minor inaccuracies regarding the animal's date of birth.
Actions:
Corrections are made in writing. Prior notification by telephone is not required in these cases.
Category 1 – No laboratory error
This category primarily covers incorrect information provided by the submitter regarding the patient or sample, as well as the cancellation of requested tests.
Actions:
Incorrect information can generally be corrected, provided this does not compromise the validity of the test result. For examinations with specific patient identification requirements—such as those for travel purposes—the admissibility of any modification is assessed on a case-by-case basis.
-
2.3 Labelling and generation of the corrected test result
The original test result is marked in the database with the notation "Result deleted," along with the name of the person making the change and the date of the modification. The original data are retained to ensure the process remains traceable.
The corrected test result is marked with a clear notice stating "Attention: Result correction!!!" and an indication of the reason for the change. This makes it evident that a correction has been made and explains why the original result was replaced.
Examinations that are no longer required are cancelled in the database by the responsible veterinarian. In these instances, too, the name of the person making the change and the date are documented; the original entries are retained.
3. Special regulations for travel-related certificates
Certificates for examinations related to international movement of animals are subject to specific requirements regarding animal identity and the accuracy of documented information. Consequently, amendments are made only in justified, exceptional cases.
Amendments may be considered under the following circumstances:
- Critical laboratory error (Category 4): e.g., an incorrect test result or a sample mix-up.
- Non-critical laboratory error (Category 2): e.g., an error when transcribing data from the submission form.
- Incorrect information provided by the submitter: amendments are permitted only to the extent described below.
Amendments subject to the following conditions
- Non-critical information, such as the animal's name, may be corrected in accordance with applicable guidelines.
- Only with written justification from the submitter Critical information—specifically age or date of birth and the date of sample collection—may only be amended upon receipt of a written justification from the submitter.
- Only with written justification from the submitter Transponder numbers may be corrected only in cases of minor input errors. Permissible corrections include the transposition of two digits (e.g., "12" instead of "21") or the replacement of a single digit (e.g., "1" instead of "0"), provided the last digit of the transponder number is not affected. A written justification from the submitter is required.
Not permitted
Complete replacement of the transponder number or alteration of significant portions of the number is not permitted. Similarly, in the event of transponder loss, alternative transponder numbers will not be retroactively entered into the existing certificate.
3.1 Documentation and provision of amended certificates
Amended certificates bear an amendment stamp indicating the nature and reason for the amendment, the processor's initials, and the date of the amendment.
Digitally signed certificates are re-signed digitally following the amendment. Certificates provided online are updated or re-uploaded; The original version remains available online to ensure the traceability of the change.
Certificates that have already been physically dispatched are recalled for archiving purposes.
4. Our commitment to transparency and traceability
Every correction of test results and every permissible modification to a certificate is documented in a traceable manner. The nature and cause of the change, as well as the measures taken, are recorded in accordance with the specific procedure involved.
Our goal is to identify errors or discrepancies promptly, limit potential impacts, and ensure the accuracy of our test results. Through documented processing and the clear identification of modified documents, we guarantee a high level of transparency for our submitters, customers, and competent authorities.