The introduction and implementation of standard operating procedures (SOPS) is extremely important in biobanking. This is because one wants to maintain a high quality of stored samples that closely resemble the biospecimens that need to be worked on. SOPs help ensure no problematic variables are introduced during the processes needed to store samples in biobanks and biorepositories. They provide a framework for biorepositories in how to conduct basic operations for each process. It is important that SOPS are reviewed regularly, especially when there are major changes in factors such as regulations, legislation, and technological advances that affect biobanking services.
Relevant Standard Operating Procedures
The National Cancer Institute’s Biorepositories and Biospecimen Research Branch makes recommendations regarding the SOPS that should be incorporated in every large biorepository and individual laboratory biobank. The minimal SOPS that should be established by biobankers include the following:
Informed consent documentation should be obtained and included for each biospecimen collected. Protocols for obtaining the consent and protecting the privacy and information of identifiable human clinical study participants should also be established.
Protocols ensuring the calibration, upkeep, monitoring, and repair of equipment used in preparing and storing biospecimens in the biobanks also need to be established. This includes making sure that operational settings are regularly recorded and that scheduled maintenance and repair of this equipment is clearly noted.
Procedures regarding the reagents and consumable supplies used during the collecting, processing, and storage of biospecimens must also set up by biobanks and they must comply with the necessary standards. These protocols need to make sure that these supplies are purchased through the correct channels, thus making sure that legitimate vendors are supplying the correct products.
Correct and adequate processes need to be put into place regarding how biospecimens are labelled and how they are linked to patient informed consent and other data sets.
Clear instructions need to be set up regarding the collection, processing, handling, and storage of biospecimens. This includes incorporating detailed information regarding the supplies, procedures, equipment, and processes that need to be used to divide the specimens into numerous sections. The names of personnel, and dates and times of processing should also be included to record where any pre-analytic problems may be encountered.
Procedures regarding the storage and retrieval as well as the adding and withdrawal of biospecimens should also be established at biobanks and biorepositories.
Defined policies and procedures must be put into place regarding shipping and receipt of biospecimens. An important aspect with shipping these specimens is that they need to be packaged adequately and with strict temperature controls in place. This includes incorporating the correct products necessary to maintain cold temperatures such as liquid nitrogen, dry ice, and wet ice, the instructions for maintaining appropriate temperature control, and delivery notifications and confirmatory documents regarding the shipping process.
SOPS should also be established to govern quality-controlled testing procedures and to document the results. These tests should assess and control the quality of the biospecimen, and confirm the diagnosis through histolopathological investigations.
Policies for the management and data collection of biospecimens must also be incorporated.
Biosafety protocols regarding reporting of staff injuries, utilization of protective equipment, precautions that need to be taken regarding exposure to bloodborne pathogens, handling of hazardous materials, and the disposal of biohazardous and medical waste products must also be established.
Training protocols for staff working with biospecimens in biobanks and biorepositories should also be documented and incorporated.
Security policies regarding technical, administrative, and physical security as well as information on points of contact must also be implemented.
Responsibility and Accountability of Standard Operating Procedures
SOPS must be reviewed and approved by the biospecimen resource director of the biobank and/or the person responsible for the quality control program of the company.