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

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.