A kit rejection refers to an entire self-collection kit that cannot processed by the lab, either temporarily or indefinitely. This differs from some instance in which just one sample or just one test is unable to be run. Those will be released as test results. More information about these results are included in the test result FAQ section.
A kit rejection from the lab will include a reason for the rejection and whether the kit is “recoverable” or “non-recoverable.”
Recoverable kits indicate that the samples can be placed back into production once the issue is resolved. Recoverable samples will be taken out of production for 7 days to resolve the issue, after which they will be discarded. ******
Non-recoverable kits indicate that the samples cannot be processed and are primarily issues with the samples. Non-recoverable samples will be discarded immediately. Patient will need to be notified that their kit was rejected by the lab, and a replacement kit will need to be ordered.
Below is a list of possible rejection reasons, along with the recoverable status.
| Rejection Reasons | Recoverable? |
|---|---|
| Quantity Not Sufficient (QNS) | No |
| Hemolyzation (blood) | No |
| Individual specimen leak, quantity insufficient for testing | No |
| Invalid specimen type / collection device | No |
| Sample integrity compromised | No |
| Cross-contamination: sample spill resulting in possible contamination of multiple specimens | No |
| Specimen over-filled | No |
| Specimen damaged during shipment, unable to test specimen | No |
| No specimen provided | No |
| Unknown collection site | No |
| No patient identifiers listed on the sample container / envelope | No |
| Expired device | No |
| Collection date exceeds 30 days | No |
| Collection date exceeds acceptance criteria | No |
| Kit not used | No |
| Outside of CLIA certification* | No |
| Electronic order issue | Yes |
| Unregistered kit / lab order not provided | Yes |
| Pending review | Yes |
| Patient identifier does not match electronic order | Yes |
| Sex assigned at birth / collection device discrepancy | Yes |
| Missing one (1) patient identifier on the sample container or envelope | Yes |
| Missing DOB | Yes |
| Missing barcode | Yes |
| Rejected per distributor or patient request | Yes |
*For labs that do not operate in 50 states and receive a sample from a state not in their certification