A sample testing project begins with the following steps:
To request a pricing bid, you will need to provide the following information:
To determine the appropriate testing, you can compare your protocol requirements and project specifications with our tests as described in our test catalog. If you have questions about specific tests, you can provide the Mayo test ID to your project manager, who will gather additional information from the testing lab.
Residual samples are not routinely returned. However, you can discuss exception requests with your project manager.
The laboratory services agreement details how results will be provided. We do not use data transfer agreements or specifications, because we do not provide data management services typically associated with clinical trials.
Authorized users can access test data and download results through the MayoLINK ordering system, when MayoLINK is used for test ordering.
Electronic data transfer is not currently supported. If orders are placed through the MayoLINK ordering system, test results can be viewed online or downloaded. For manually placed orders, results are transmitted via facsimile (fax).
BioPharma Diagnostics treats all samples with equal importance and is unable to expedite specific samples. Upon receipt, all samples are accessioned and sent to the lab.
You can order tests through the MayoLINK online ordering system. When orders are placed in MayoLINK, results are delivered through the MayoLINK system and can be downloaded as PDF, JPG, TIF, PNG, TXT, or CSV files. You will be notified by email when results are available. All paperwork needed for accessioning your sample is provided through MayoLINK. A requisition form and label with the required information for sample intake and testing can be printed.
You can also order tests manually. Specimens can be submitted with completed requisition forms or manifests. Samples are manually accessioned at our facility. Results are returned via facsimile (fax).
Note: Result reports will contain specimen information as provided when orders are placed. Data management services are not provided by BioPharma Diagnostics.
We adhere to the published turnaround time whenever possible. However, sometimes extenuating circumstances, such as equipment malfunctions or other issues beyond our control, can result in a turnaround time that is longer than expected. In these situations, you will be contacted as soon as possible.
Customized flagging and reference ranges are not currently supported.
Shipment deliveries can be tracked by using your courier tracking number. If orders are placed through the MayoLINK ordering system, you can track individual specimens from receipt through testing and resulting within the MayoLINK system. For manually placed orders, specimen tracking is not available. Separate sample receipt reports are not supported.
Sample stability is discussed at the beginning of each project. Samples that are outside of the published stability parameters must be approved by the laboratory director before they can be accepted for testing.
Clinical accounts are used only for clinical diagnostic testing. A separate research account is recommended for sending in research samples. After the laboratory director approves your testing to ensure that it meets stability, labeling, processing, and billing specifications, the research account is created.
The specimen label must include two identifiers that exactly match what is ordered in MayoLINK or what is displayed on your requisition or shipping manifest. You can use your subject ID as one of the identifiers and a sample number as the other identifier. BioPharma Diagnostics staff will work with you on matching the identifiers and completing the required fields. In many cases, de-identified data can be used in place of PHI.
The shipping address and contact information will be provided to you after the contract is finalized.
With approval from the performing lab director and supervisor, substituted specimen types can be accepted.
Mayo Clinic Laboratories is open 24/7/365. However, individual carriers might be closed and might not make deliveries on recognized holidays. The following holidays are observed in the United States:
Note: Contact your preferred carrier for local holiday information.
You will send samples to Mayo Clinic Laboratories after a contract has been finalized and your account setup has been completed. The shipping address and contact information will be provided to you at that time.
If the test catalog indicates that supplies are provided for a specific test, then you can submit a request to your project manager at BioPharma Diagnostics. You will need to specify the supply number described on the Specimen tab for the specific test in the test catalog (e.g., T465). In addition, you will need to provide the quantity of supplies needed, your client account number, and your shipping address.
To order supplies for collecting and shipping test specimens to Mayo Clinic Laboratories:
Payment options include check, automated clearing house (ACH) bank transfer, or credit card.
Invoices are typically available at the beginning of each month and show charges for testing that was performed the previous month in addition to any pending balances from previous months. Email notifications are sent to your billing representative when invoices are available.
To access invoices, sign in to mayocliniclabs.com.
BioPharma Diagnostics permits a site qualification visit, which includes a tour of our facility and review of standard operating procedures. However, we do not allow routine audit monitoring visits, where we would pull records for your specific study.
Our training is based on College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) requirements rather than GCP, and all employees complete annual competency assessments with seven required elements:
For general requirements, refer to Instructions by Specimen Type.
For specific requirements, search for a test in the Test Catalog and refer to the Specimen and Performance pages for that specific test. Special Instructions and Forms are also available on the Specimen page when applicable.
If no specific collection and preparation instructions are provided by Mayo Clinic Laboratories, refer to manufacturer or regulatory guidelines.