Investigator Site Resource Centre

Dedicated site to assist users of ICON Central Laboratories' Services

FAQs


Specimen Preparation

I recently received a lab report that indicated a specimen was "hemolyzed." What does that mean and what caused that to happen?

Hemolysis refers to the destruction of red blood cells which leads to the release of haemoglobin from within the cells. Hemolysis affects specimen quality and, consequently, can affect the results for certain laboratory tests. Site personnel can prevent hemolysis by avoiding the circumstances that can cause it. These include:

Too great a vacuum in the vein, causing the red cells to be drawn toward the bore of the needle too quickly. Also the red cells could be forced through too small an opening too quickly. Using too large a vacutainer tube on too small a vein.m Too slow a flow of blood into the tube, indicating that the flow is somehow obstructed (such as the opening of the needle being too close to the upper or lower lumen wall). Using too small a gauge needle for the vacuum applied to the blood collection system (be it variable by syringe or constant by vacuum draw system). Too large a gauge needle resulting in too great a vacuum pulling too much blood through the opening too quickly. Vigorous mixing or shaking of the filled collection tube. Not mixing an anticoagulated sample after it has been collected. Centrifuging an anticoagulated blood sample to check for hemolysis.

The lavender-top tubes that I sent to your laboratories could not be processed because the specimen clotted. How did this happen? What can be done to prevent clotting?

Specimen clotting usually occurs because the collected blood does not mix thoroughly with the EDTA preservative that is contained in the tube. To avoid this problem collect the specimen, then invert the tube 8-10 times at approximately a 180° angle (the equivalent of a semi-circle). This procedure will permit the EDTA to thoroughly mix with the specimen so that clotting does not occur. Also, do NOT store this type of sample at a refrigerated or frozen temperature prior to shipping. Your ICON Laboratories Investigator Manual provides step-by-step, illustrated instructions that should also be helpful in properly preparing this specimen.

Why do I have to prepare Peripheral Blood Film slides when sending a CBC with Differential to the lab? How do I properly prepare the slides?

Preparing and sending a quality Peripheral Blood Film is a critical procedure to ensure that accurate test results are reported for your study subject. When the specimen you collect for the a CBC with Differential arrives at our laboratory , the testing is performed on an automated instrument. If the instrument detects an abnormality, or requires confirmation, a laboratory technologist will perform what is known as a "manual differential." To ensure that the specimen abnormalities are not due to specimen transport issues or time delays, the laboratory relies upon slides made from freshly collected blood, prepared at the investigator site at the time of specimen collection. Since proper preparation of the Peripheral Blood Film slide is so important, we have provided a brief video that demonstrates the proper preparation procedures. View Video Here.

Does it matter how I place the bar code label on the collection tube?

YES! The bar code is the primary means of tracking the sample at our lab from the time of receipt through testing and storage. To ensure that it can be scanned appropriately the bar code should ALWAYS be affixed so that it is aligned with the tube (The bar code should not go around the tube.) It is also important that the label not cover the tube cap. Proper labeling facilitates scanning and prevents delays in reporting. Also, please remember to affix a bar code label in the designated place on each copy of the requisition to properly link the requisition to the samples submitted for that visit.

 

Holiday Hours

How do I ship to ICON Central Laboratories on a holiday?

ICON Central Laboratories WILL be open to receive, stabilize and process samples on holidays. However, in order to ensure that samples are picked up and delivered to our laboratories on a timely basis, it is important to take the following factors into consideration:

  • A - Check the holiday schedule for your site's courier service used by your site to ensure that there will be no problem with specimen pickup from your site or delivery to our laboratory, due to the courier's holiday schedule.

    • The following couriers DO NOT operate on official holidays; therefore it will be important to contact your local courier office or visit their website, if such information is available on-line, to obtain their holiday schedules.
       
    • Federal Express
    • DHL
    • TNT
       
  • B - The following specialty couriers DO operate on holidays. However, your site may be required to obtain sponsor authorization prior to using one of these couriers due to cost or other factors.

  • If the courier holiday is observed on a Monday, please be certain that specimens picked up from your site on Friday are clearly marked for Saturday delivery. This includes appropriately noting the airbill and placing "Saturday" stickers on the shipping package.
  • If the holiday falls the day after pickup from your site or coincides with a weekend, it will be important to ensure that no unusual delay in delivery will occur that might compromise specimen integrity. For example, if the courier picks up your specimen on Friday, but the courier observes a holiday on Saturday, your specimen will not be delivered to our facility until the following Monday. This delay could compromise specimen quality and you may want to consider postponing the specimen collection or preserving the specimen for shipment after the holiday (if the specimen type permits).

If you have additional questions regarding shipping procedures during holiday periods, please contact one of our Site Service Specialists.

Kits and Supplies

I’m collecting specimens from a study patient today and I don’t have the visit specific kit required. Can I use an "Unscheduled" kit?

If you received study-specific "Unscheduled" kits in your initial shipment – then yes, you can use an "Unscheduled" kit. Examples of "Unscheduled" visit kit names include "UNSCHEDULED" / "UNSCHED" / "UNSC/ETERM" / "UNS/RETEST".) Collect only the tubes that are necessary for the specific study visit. To prepare the requisition in the "Unscheduled" kit:

  1. Locate the requisition in your "Unscheduled" visit kit.
  2. Complete the demographic and collection information sections of the requisition as per usual.
  3. Make note of the Visit Type in the Visit Type section of the requisition (e.g. Visit 3 or Repeat of Week 9).
  4. Use the checkboxes in the Test section of the requisition to indicate the test(s) to be performed based on the study-specific testing for the subject’s actual visit.

If there are no "Unscheduled" kits for your study or if you do not have an "Unscheduled" kit on hand, you may use a kit for another visit that contains the necessary collection supplies. Be sure to remove any supplies from the kit that are not necessary for the visit being collected. When completing the requisition, be sure to cross out the visit name on the requisition and write in the name of the visit for which you are using this "replacement" kit.If neither of these options is possible, contact our Site Service Specialists at for assistance.Important Note: Be sure to call us for more supplies or fax a Supply Reorder Form immediately, to prevent this problem from occurring in the future.

I’m out of kits/supplies. Is there any way I can receive them by tomorrow?

Possibly. Telephone ICON Laboratories’ Site Service Specialists and let them know of your need. "Overnight" kit/supply requests must be received by ICON Laboratories’ before 2:00 p.m. (EST) for expedited service. If you have previously re-ordered supplies, be sure to let the Site Service Specialist know, so that the existing order can be expedited overnight. ICON Laboratories will make every effort to accommodate your request but we cannot guarantee that your supplies will arrive the next day. Important Note: Please allow 7-10 business days, from the time the Supply Reorder Form is faxed, for delivery.

The visit kit has expired, but the patient is here. Is there anything I can do to still use it?

Yes. Replace any expired tubes in the kit, if possible. Please note on the study requisition that the tubes were replaced. This will avoid queries from ICON Laboratories regarding the use of supplies that were not originally in the kit.

Last Wednesday I requested a re-supply of kits for my site. It’s now Thursday of the following week. Why have they not arrived?

ICON Central Laboratories requires 7 business days for kit delivery within the U.S. and 10 business days for deliveries outside of the U.S. It is important to note that Saturday and Sunday are not business days for our kit re-supply department. If you are located in the U.S., your order should arrive on Friday of the week following your Wednesday order. Using the same scenario, if you are located outside of the U.S., your re-supply order should arrive on Wednesday two weeks following your order. Routinely checking your supply inventory and taking into account the non-business days when you place an order will help ensure that your supplies are there when you need them.

The study in which my site participated has ended. I have unused collection supplies. What should I do with them?

Collection supplies should not be returned to ICL. If supplies have not expired, they may be used at your clinic for patient care, if permitted by your clinic’s policies and procedures. Otherwise, all collection supplies should be disposed of in accordance with local regulations for disposal of such items.

Specimen Shipping

I cannot ship my samples today. How should I store them?

Every effort should be made to ship specimens on the day of collection, except for specimens for which batch shipment has been approved. However, for those rare occasions when same day shipment may not be possible, specimens should be collected, prepared and stored at the same temperature they are to be shipped, as indicated in your lab manual. Please be sure to ship the specimens the following day or the next day that courier service is available, if collection has occurred over a holiday or weekend.

What steps do I need to take to ensure samples drawn near the weekend are delivered to the laboratory?

When shipping samples to ICON, it is important to bear in mind some additional items when weekend shipping is involved.

  • If your site has 24 hour transit to ICON, any samples shipped on Friday must be shipped for "Saturday delivery".
  • If your site has 48 hour transit to ICON, the last shipping day should be Thursday - to ensure samples are delivered to the laboratory on Saturday. Again "Saturday Delivery" must be requested with most couriers.
  • Most couriers DO NOT offer pick ups from sites on Saturdays so it is important to ensure that you bear this in mind when planning subject visits and if any special requests are required, please contact our Site Services team.


How do I ship specimens collected on Saturday?

If your facility has Saturday courier pickups, ship ambient specimens as usual. Refrigerated boxes are temperature-validated for 48 hours; so refrigerated specimens may also be shipped as usual. The specimens will be delivered to our laboratory on Monday. Frozen Specimens should be stored frozen at your site for shipping on Monday to ICON Laboratories. If your site does not have Saturday courier pickups, hold specimens for Monday shipment. Be sure to check the stability of the specimens for the protocol/visit in question. Ambient and refrigerated specimens should be refrigerated. Frozen specimens should be frozen at the recommended temperature.

How do I ship specimens collected on Sunday?

The study sponsor must give authorization for Sunday shipments since special couriers are required for such pickups. If your site has received such authorization, your ICON Laboratories Project Manager can provide you with the specific information that you will need in order to obtain a Sunday specimen pickup. If your site has not received the necessary sponsor authorization, it will be necessary to appropriately store the specimens until Monday. (For additional information about proper specimen storage, please refer to the answer provided to the first question in this section.

How do I ship specimens collected on a courier holiday?

Most sites are not automatically authorized to ship on courier holidays. If the study sponsor has authorized such shipments for your site, ICON Laboratories’ Site Service Specialists can provide you with the specific information that you will need to obtain a holiday pickup. You may also consult the 'Holiday Hours' section of this 'Frequently Asked Questions' section for additional information about courier holidays and holiday shipment.

At what temperature should I ship study specimens?

A. Appropriate shipping temperatures vary, depending upon the types of specimens collected at each visit. Please refer to the ICON Laboratories Investigator Manual and visit-specific requisitions for the specific information on proper specimen shipping temperatures.

Why are specimens for the same tests shipped at different temperatures for different visits?

ICON Laboratories staff members carefully review each visit’s test list with temperature and stability requirements. Since some specimens have very stringent temperature requirements and others have a range of acceptable temperatures, ICON Laboratories can determine the type of shipper and shipping temperature that will make packaging and shipping easiest for the study site. Consult the packaging section of your ICON Laboratories Investigator Manual for more specific information, based upon the type of shipper being used.

How many specimens should I ship in a single shipping box?


The number of specimens recommended for shipment in a single shipping box depends upon the type of shipper being used. Consult the packaging section of your ICON Laboratories Investigator Manual for more specific information for the type of shipper being used. Generally, refrigerated shippers can hold specimens for 3-4 study subjects' specimens. If your site is using cryoboxes for frozen specimens, the number of specimens will be based upon the number of tube sections in the box. If your site is using sealable bags for frozen specimens, you may ship as many specimens as will fit in the bag, provided that sufficient room remains in the foam insulated shipper for the recommended amount of dry ice, after the bag is placed there.

How do I properly package specimens in a refrigerated shipping box?

Each refrigerated shipper contains two ice packs. These must be frozen for 12 hours prior to shipment. One frozen ice pack is inserted into each of the outer slots of the shipper. Place the biohazard bags containing the specimens into the center slot. Be sure that the specimens do not make contact with the ice packs, as this may compromise specimen temperature. For more detailed packaging instructions, refer to the ICON Laboratories Investigator Manual.

My courier doesn't provide dry ice. How can I obtain dry ice to ship my frozen specimens to ICON Laboratories?

There are many non-courier companies that can provide dry to you. For more information about dry ice services click on www.dryicedirectory.com or contact your ICON Laboratories Site Services Department for further information.

Laboratory Reporting

I received a laboratory report with the comment, "Specimens were received beyond the limits of stability." No test results were reported. Why did this happen and what can I do?

ICON Laboratories reviews the time that has elapsed from the specimen’s collection to its receipt in our laboratory. If this time period is longer than the period for which that specimen type is known to be stable, we will not perform the test. This is an important quality control procedure to ensure that accurate data is reported for the study. The protocol for your study may permit re-drawing the subject for that visit. Check with your study monitor, if you are not certain. Also, try to determine why the specimen may have been delayed reaching our laboratory. If you have concerns about timeliness of specimen pickups and deliveries by your courier, please contact our Site Service Specialists for assistance.

I am receiving laboratory reports from ICON Laboratories that only report some of the tests performed at the patient visit. Why is this occurring?

The sponsor of study has requested that ICON use a feature known as "partial reporting" for the study. This method of reporting is often selected when some tests required in the protocol take longer to process than others. For example, the study may require basic safety testing as well as microbiology testing. It may take several days to determine if the specimen is growing certain types of bacteria in order to issue an accurate laboratory report. However, safety test reporting is available within hours. To ensure patients’ safety, such tests are reported immediately so that appropriate medical monitoring and follow-up can occur. The tests requiring longer processing periods are then subsequently resulted on a separate report.

The clinical protocol that our site is involved in requires a drug screen with confirmation. We received a report from ICON Laboratories that reported the initial screen as "positive" and the confirmation testing as "pending." How do I know whether to enroll this patient or not?

A positive screen is indicative that the subject screened positive for the drug class in question. No specific drug in the drug class can be identified from an initial screening test. Consequently, the specimen undergoes confirmatory testing to determine the specific drug or drugs present in the urine sample. In some cases, even though a screening test is positive, the confirming test may be negative. There are several reasons why this could occur:

  • The substance is below the detectable limit of the confirmatory test.
  • There are hundreds of drugs within a certain drug class, and we only test for the most commonly found substances; therefore, the subject could have been exposed to a drug in the class for which we do not run confirmatory tests.
  • Cross-reactivity with any number of other substances, such as herbal remedies, drugs from other classes or harmless substances, such as poppy seeds.

Regardless of the circumstances, you will most likely need to await the confirmatory results and consult with your medical monitor for the ultimate determination as to whether or not it is acceptable for the subject to continue in the study.

Why do I receive multiple laboratory reports for the same subject's visit?

Your study sponsor has several options for how they would like for ICL lab reports to be distributed to their investigator sites. They select the option based upon the tests being performed for the protocol, test turnaround times and any special subject safety considerations. If you are receiving multiple reports for the same subject visit, it is most likely because the tests may have significantly different processing and turnaround times. Reporting results as they become available, rather than waiting until all tests for the visit are completed, ensures that safety testing is reported as soon as possible, enabling more timely clinical monitoring of study subjects.

I received a laboratory report that had the comment, "Held for Verification." What does that mean?

ICON Central Laboratories prints this comment on the laboratory report to make the site aware that, although testing was performed as soon as the specimens arrived at the laboratory, the lab report was delayed for release until some missing or discrepant information could be resolved by querying the site.

Requisitions

What happens if I send the lab requisition to ICL without all of the required information?

The one word answer is delays. It is extremely important that sites provide ALL required information on the lab requisition at the time of subject collection. This information is critical to providing proper test results. For example, determining whether a subject’s lab value is within the normal range is highly dependent upon the subject’s age and sometimes gender and race. Consequently, ICL cannot produce a laboratory report until this information is documented, resulting in delays that could impact the safety and appropriate clinical management of the study subject. It is important to note that when ICL receives incomplete laboratory requisitions, we continue to process the specimen for testing; however the laboratory report is held until our Site Services department can obtain full information from the site.

Site Support

Sometimes when I call Site Services, I’m told to contact my study monitor to obtain the answer to my question. Why?

ICON Central Laboratories’ Site Service personnel are not physicians and therefore cannot provide clinical interpretations of laboratory results or give medical advice. Consequently, callers with such questions are referred to their Study Sponsor’s medical monitor for appropriate guidance.

Certificates and Licenses

I noticed that the College of American Pathologists (CAP) certificate I have on file has expired. How do I obtain an updated certificate?

You can easily obtain the most current certificates and licenses for our laboratories by visiting the Investigator Site Resource Center of ICL’s website. The link to certificates is: http://www.iconplc.com/investigators/investigators-resource-ce/lab-certificates/

Please note that there is often an inherent delay between the time our laboratories are re-certified or re-licensed and the time we receive the actual certificate or license document. In such cases, we will post a letter that documents the status of the certificate or license. You can download and print this letter to document your files until the new certificate or license is posted.