Proper AP Sample Identification

AP video picAnatomic Pathology (AP) is the study of solid tissue, and is often a critical part of many protocols. Tissue samples are used in clinical trials in addition to the usual blood and urine samples. Examples of anatomic pathology samples Covance Central Laboratory Services receives for clinical trials are tissue from the gastrointestinal and urinary tracts, endometrium, liver, skin, lung and bone marrow.

AP slide imageAccurate patient identification is of utmost importance when sending Anatomic Pathology specimens as in almost all cases, unlike blood or urine samples, solid tissue samples cannot be recollected. Therefore the audit trail must be tighter and specimen ID is held to the highest standard. Imperfect specimen ID may result in the specimen being returned to the investigator site.

Tissue samples can be submitted in various forms; Wet tissue, Tissue in a paraffin block, or Tissue on a slide.
Some tissue samples are newly obtained from patients during the course of a clinical trial. These fresh samples are normally submitted “wet” in formalin.

They are identified with the barcode accession number affixed to the Covance CLS provided sample container and the Patient ID written on the label and the requisition. Be sure to write the patient ID using indelible marker on the accession label that matches the requisition.AP bottle image

Some tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

 

tube with slide for AP blog articleSome tissue samples may be submitted from an archive of tissue samples from a patient. These archival samples may be already labeled using local hospital or clinical procedures. When the Sponsor wants to use these tissues for analysis, it is extremely important to provide a durable and defensible audit trial….tying the local patient identifiers to the Covance accession number used in the clinical trial.

Archival AP samples are normally submitted along with a copy of the local pathologist’s report which includes the sample’s local identification. Use the extra accession label from within the Covance CLS kit and apply it to the local lab report. This ties the local lab report to the clinical trial. Handwrite the patient’s clinical trial patient number or initials on the label. Also, be sure to use a black marker to obscure any confidential information such as patient’s name, address, social security number, etc.

In a sampling of specimens received at Covance CLS, we found AP sample identification errors to be 10 times the error rate for blood and urine samples! In order to preserve unique tissue samples we want to share successful practices with you. These will reduce the error rate ensuring the sample can be used for inclusion and analysis in the clinical trial. Please review the eLearning on Anatomic Pathology Sample ID for tips in proper labeling to prevent common sample identification errors. 

By working together, we can reduce specimen identification errors and increase delivery of accurate results. Careful attention to specimen identification promotes quality patient care and a successful clinical trial.

A Recipe For Success: Kit Substitution

kit-best-practicesThis article originally appeared in late 2014. However, the information is still relevant and may help sites when faced with the need to substitute a kit, especially given the recent K2 EDTA tube recall.  Please see this notice which was shared with impacted sites.

Substituting kits is a lot like substituting ingredients in a recipe: you have to find the item that is closest to what you are missing. Of course, It’s best to not have to substitute one kit for another, or with our example above, one ingredient for another, but sometimes a situation develops where you have no choice and have to find the best match.

To avoid that last minute scramble, it is important to monitor all site supplies and expiration dates. This should be done routinely and well in advance of any patient visits. Kits can be ordered on our resupply website at:www.covance.com/kitordering. It’s important to be aware of the number of days required for resupply as it varies by region. This information is also available on the website. Continue reading

Hurricane Irma Preparations

Covance Central Laboratory Services Logistics would like to provide the following information regarding potential courier service delays due to Hurricane Irma.

Investigator Sites in Florida can expect to experience unavoidable service delays by your courier, based on the current or anticipated severe weather in your area. Although contingency plans are in place, some disruption in pickup or delivery service is anticipated by all couriers in Florida.

If your site is located in the impacted area, sample collections should be avoided if at all possible. Contact your normal courier prior to sample collection to confirm if pickup is available in your area.

If you have already drawn samples and your courier is unable to provide sample pickup, please maintain your specimens at the designated transport temperature until the next available pickup. Maintain ambient samples at ambient temperature, frozen samples in a frozen state in a freezer or on dry ice, refrigerated samples should be kept refrigerated.

Couriers will resume normal service schedules as soon as the situation allows. You can obtain further courier service weather updates by visiting your courier’s websites (ups.com or fedex.com).

If you have any questions regarding this information please contact Covance Investigator Support at 866-762-6209.

 

 

Timelines for Data Revisions

If a data revision has been requested for change of collection date, time, weight, visit, etc., the request may take up to 8 to 10 business days. hourglass

Once the change is complete, a fax will be sent to the site reporting the change has been made. A new report will not be sent. If a new report is needed please call Covance at the number listed for your area in the Contacts’ section of the laboratory manual.

 

New Investigator Website
Provides One-Stop Shopping

new Invetigator webpage image for blogThere is a new and improved website just for you!  The new Investigator Services website is up and running and contains numerous resources for investigator sites.

We gathered all the resources that sites might want and listed them so you could easily find what you needed on one page.   What’s available:  Everything from training videos, to centrifuge instructions, to contact numbers and much more.

Go to Covance.com  to see the new page and bookmark it or add it to your favorites so you will have easy access to these resources.

Laboratory Certifications

Covance Central Laboratory Services would like to remind sites that Laboratory Certifications are updated periodically, and are always available via the following link: http://www.covance.com/customers/investigators/investigator-tools-and-resources/accreditations-and-certifications.html

These certifications are only updated in the investigator manual once per year during an annual Standard Page Update period.  The link currently listed in the investigator manual is no longer in operation.

​Please use the link above for all current lab certifications.

How to Avoid Cancelled Orders

After placing your online kit order through our website, please make sure you receive an order confirmation email; this means that your order has been successfully submitted.

Additionally, regularly check your inbox for potential queries from our Kit Inventory Department who will contact you if your order contains incorrect information (i.e. wrong protocol or site number). See example below.

If the query is not answered within 24 hours for expedited / 48 hours for standard, your order will be cancelled.

insite blog pic 26 Jul

The Importance
of a Project Number

A project number is another way to identify your Covance protocol. This information is particularly useful when ordering kits and supplies as it identifies which arm/phase/branch/region applies to your study.  Project numbers are six-digits long and can be found on the cover of your Covance Laboratory Manual and on every requisition in the left, lower corner.

 

2017 Holiday Shipping Guidelines

At Covance, we know you are busy! To simplify, we are reducing the amount of communications you receive from us regarding holiday reminders.

We will no longer be sending out multiple communications throughout the year. Everything you need to navigate the global holiday season is conveniently located in the links below.

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http://www.covance.com/content/dam/covance/pdf/holidays.pdf

Holiday+Image2

http://www.covance.com/customers/investigators/investigator-study-team/courier-contact-numbers.html

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http://www.covance.com/content/dam/covance/pdf/English_CovanceCLSContactNumbers.pdf

Remember – All Holiday reminders are available on the Covance website:

http://www.covance.com/customers/investigators/investigator-study-team.html