Quality control
and SOP
From order to delivery, we take care that every sample arrives with the highest quality researchers need to ensure confidence in their results
BioPartners, Inc. have developed its own Multi-level Quality Management and Control System which allows us to claim industry leading compliance and quality control certifications.
We are constantly improving ourselves and we strive to provide the best biospecimen procurement services available. That starts with a complete and thorough understanding of all applicable laws and regulations. The principle of excellence we apply to every aspect of the detailed and study conduction and biospecimen collection involves everything: from the choice of the best quality supplies to involvement into the study the best medical experts. All of the samples collected at our foreign clinics are procured and manufactured using validated SOPs and under the oversight of a local IRB(s). All our subcontractors act under internationally recognized licenses and certificates, including ISO 9001:2015 provided to our exclusive vendor BioPartners, LLC in 2019.
Samples collection and quality of the provided clinical data at the clinical sites are regularly monitored, queries or deviations (if any) are always effectively resolved. Special attention is drawn to the quality of document circulation and retention.
The high quality of the product directly depends on high qualification and expertise of the involved personnel, that is why we take care that our employee undergo regular training courses and participate in the international specialized conferences.
All our samples are de-identified; unique code (containing patient’s ID and sample type indicator) is assigned to every sample. Each container with biospecimen, tube, and cassette or glass slide is accurately labeled, so that the samples information is clear and readable, moreover, it can be scanned due to the QR code on each label. For prospective collection, we can prepare label design with bar- or QR code on Client’s individual request.
how we work
BIOSPECIMENS COLLECTION QUALITY CONTROL
Blood and blood derivative samples are processed and frozen at -70°C or lower temperatures within 2 hours after draw. Plasma samples are double spun to ensure proper blood fractionation. Samples are checked for hemolysis after processing. Hemolyzed samples are discarded and are not stored for distribution.
Tissue samples are collected and properly fixed within the shortest possible ischemia time, within 30 minutes of surgical excision. Despite the type of collection (e.g. fresh, frozen or FFPE), additionally to the tissue sample collected for the study, a representative piece of tissue is cut off and used to prepare a representative FFPE block and H&E slide for the purpose of QC. Low quality tissue samples or those with high necrosis content are discarded.
PATHOLOGY QUALITY CONTROL
H&E slides are prepared from every FFPE tissue block collected for BioPartners. These H&E slides are reviewed by a certified pathologist to confirm tissue identity and appropriate histology, and to ensure that the representative cellular components are present in the collected tissue specimen. Each H&E slide is ensured to match the confirmed diagnosis in the pathology report. Pathologists reject the specimens that do not meet quality standards of the research.
CLINICAL DATA QUALITY CONTROL
Clinical data collection, as well as blood or tissue sampling, can take place only after Consent Form is obtained. All data is collected into the specifically designed for the study Case Report Form (CRF). All data is cross-referenced with patient charts and reviewed for accuracy and completion. All data is ensured to correspond with pathology information provided by the collection site. Any identifying patient information is redacted from all pathology or laboratory reports and summarizing clinical spreadsheets. Donors are anonymized and specimens are re-identified with a Sample ID number.
STORAGE QUALITY CONTROL
Biopartners ensures that all frozen specimens are kept frozen and never allowed to thaw. Frozen tissue specimens are stored in liquid nitrogen vapors or at -70°C or lower temperature.
FFPE tissue specimens are stored at room temperature under temperature controlled conditions.
All frozen Blood and Biofluid Samples are stored in ultra low -70°C freezers.
Freezer temperatures are regularly monitored and recorded.
All samples are checked for quality and volume before shipment.
SAMPLES MANAGEMENT QUALITY CONTROL
BioPartners, Inc. maintains pre-registration web-interface for the collected biologic samples. Before shipment, the volume and quality of all samples are inspected. Biospecimens that do not meet project specific criteria or received from the clinical site in a compromised condition are assigned deviation codes/comments to record any non-conformities prior to shipment to the client
SHIPMENT QUALITY CONTROL
For the shipment of our biospecimens BioPartners employs services of certified for biologic samples transportation courier companies (e.g. DHL, World Courier, Fedex, etc.). After a Purchase Order is placed, Biopartners will contact the client to coordinate a shipment date(s).
At the time of shipment, applicable courier tracking numbers for shipment will be provided by e-mail to the client. All FFPE tissues are checked to confirm pathology and identity before shipment. All frozen samples are shipped on dry ice or in vapor phase liquid nitrogen. FFPE tissue specimens are shipped at ambient temperature, unless requested otherwise.
The following items are included in every shipment:
• A packing slip including the list of samples
• Labeled specimens in appropriate packing materials.
Complete clinical information, pathology reports, and any other applicable data are sent electronically before or after the shipment (e.g. when fresh tissue or fluid samples are shipped the same or the next day after biospecimen collection).
Preparation of the shipment is supervised by BioPartners’ IATA certified personnel
WE ARE THE TRUSTED EXPERTS
WE KEEP THINGS running smoothly
To our Clients we offer a vast variety of human biospecimens from our stock available for order right away. In addition, biospecimens can be collected prospectively in timely manner and according to the unique needs and goals of your project.
