Frequently Asked Questions
The patient’s Serum Separator Tube wasn’t spun within 1 hour of collection.
One of the tests that I sent to you was canceled due to hemolysis.
My copy of your lab licensure and accreditation is expiring/has expired.
The patient was a difficult draw and I wasn’t able to obtain all of the required specimens.
I have a patient coming in tomorrow and I don’t have the correct kit to collect the visit.
The patient was unable to produce a urine specimen for the visit.
I shipped a kit and realized after the courier left that one of the tubes was still in the centrifuge/refrigeration/clot rack.
I need to ship a sample on dry ice.
I haven’t received a report for a lab visit that I collected.
The investigator needs one of the test results right away.
I have a lot of expired kits that I won’t be using.
I received a duplicate copy of a lab report.
I have a patient with a scheduled lab visit that falls on a holiday.
I can’t find my copy of a test requisition for a kit that I shipped to the lab.
A: Spin the specimen immediately and note on the test requisition the actual elapsed time between draw and centrifugation prior to shipping the specimen.
A: Hemolysis can be caused by several factors:
- Difficulty in obtaining blood from patient (hard draw)
- Prolonged Tourniquet use
- Use of too large or too small needle gauge for the patient
- Improper venipuncture
- Insufficient clot time prior to centrifugation
- Delay in sample separation
- Inadequate drying time after use of alcohol prep at draw site
- Vigorous shaking or mixing of the sample after draw
- Exposure to excessive heat or cold
- Patient health conditions, such as hemolytic anemia
A: The most current versions of our permits, certifications, accreditations, etc. (across both clinical & central lab services) are available in PDF format.
Historically, we do not receive an updated copy of our NYS license until 4 to 8 weeks after our inspection occurred. CAP accreditation is based on a scheduled inspection by a group from another CAP-accredited facility. These inspections may not be conducted on an exact schedule and the current accreditation is considered valid until the inspection results are provided to us.
A: Document the situation on the comments section of the test requisition and send everything that you could obtain. We will attempt to perform as much testing as possible from the available sample and notify you if any testing needs to be canceled.
A: If you have an Unscheduled Visit kit available, you may use that to obtain the specimens. If you do not have unscheduled kits, review the test schedule in Section 3 above to determine if you have a kit available for a visit with similar testing that you could use. If you have a usable kit, cross off the Visit and write the name of the visit that you need. If neither of these options is available, contact study support for assistance.
A: Document the situation on the comments section of the test requisition and send the samples that could be obtained. Contact your CRA to determine if the patient should return for a follow up visit.
A: Contact the courier service to see if the sample can still be shipped today, either by another pick up or by dropping the sample off at their terminal. If it can be shipped, package the sample with a note that the remainder of the visit was shipped separately. If the courier will not ship the sample today, refrigerate the sample overnight (if appropriate for the specimen type) and package it for shipment tomorrow. Call study support to notify them that the sample will be shipped tomorrow.
A: Dry ice is available from many beverage distributors and industrial supply companies. Some hospitals and universities also manufacture dry ice. A directory of suppliers can be found at www.dryicedirectory.com.
A: The report may not be available yet due to:
- Outstanding test results – Refer to the Reporting section for information about test turn around.
- The need to re-run and verify results
- An open data query
A: Contact our study support services to notify us of the situation. We will work with you to determine the soonest a result can be available and the best way to get the result to the investigator when it is.
A: You may discard or dispose of the kits in a manner consistent with your local regulations. The kits are manufactured specifically for each protocol and investigator site, so they may not be re-used.
A: Contact your CRA to obtain approval for the testing. The sponsor will contact the laboratory to provide approval for the testing and you will be contacted with the specimen collection and handling requirements and provided with a test code to document on the test requisition.
A: If the test is part of the normal protocol testing, then you may contact us to request that the test be added. If the residual sample is available and it is within the stability guidelines for the test, we will add it to the order. If the test is not part of the protocol, please contact your CRA to obtain approval.
A: Review the most recent copy of the report. If a data element has been modified there will be a note regarding the change to the report. It is also possible that someone at your site requested another copy be sent – check with your co-workers. Please contact study support to determine who requested the report if you are unable to resolve why the report was re-issued.
A: Contact your CRA to determine when you should collect the specimen. Refer to section 2 of the investigator manual for information about holiday shipping.
A: If you sent the yellow copy of the test requisition to the lab it will be mailed back to you, generally within a week of receipt. If it is over 2 weeks since the visit or if you know that it was misplaced at your site contact study support to request a copy of the requisition received by the laboratory.
A: This Q & A list has been developed to answer commonly asked questions.