Researchers in biomedical fields require biorepositories of high quality annotated specimens in order to carry out their work. To assure the quality and consistency of specimens, these facilities implement quality management systems (QMS). Quality management systems rely on quality control as well as other protocols to ensure that the biorepositories can deliver research grade samples to investigators in the laboratory and clinic. We discuss an article that summarizes the development of a QMS amenable to many laboratory settings.
Biomedical researchers depend on high quality annotated human and animal specimens. Biobanks house extensive collections of such samples for researchers to choose their raw materials from. Quality management systems and quality assurance (QA) programs allow them to maintain high quality and consistent samples and make them available to the scientific community. Quality control (QC) is one piece of a QMS that measures the attributed and performance of a product, process or service. These QC programs compare results to defined standards in order to maintain the requirements are fully met.
Biorepositories should have a firm understanding of bias and how it relates to the tissues that they provide. Variability in research that sources human tissue is often caused by bias. Bias takes place when confounding variables are the cause of an observation. In the case of tissues, there may be differences between patients that carry a disease versus patients that are disease free. Such considerations need to be understood in order to deliver tissues that researchers can use free from underlying bias.
The underlying model of acquisition of samples can cause QMS to vary. The collection of tissue samples can be either organized or disorganized. One model has the pathologist or researcher randomly collecting tissue for future research. There is usually not a robust QMS with an associated QC in these cases and this can result in poor quality and misdiagnosed tissue. Organized biorepositories usually utilize one of the following models: banking, clinical trial, population-based, prospective or combination.
Effective training of personnel is also of great importance. Training should include safety and regulatory information and must be delivered to anyone collecting, processing, storing or distributing tissue. Standard operating procedures (SOP) must be maintained and staff educated as to their use. SOPs are detailed documents that provide standards for all activities that take place in the biorepository. Such documents are crucial for the distribution of process-related activities. Written evaluation of SOPs, or audits, are necessary to maintain adherence to standards. One of the areas in which audits are most important is annotations of specimens. The QMS for a biobank must maintain that the patient information related to tissues and clinical and demographic information provided are accurate.
Quality control, or the monitoring the quality and diagnosis of the tissues provided by biobanks is an essential component of a QMS. A pathologist must verify diagnosis and description based on microscopic examination. Further techniques used for QC of tissue can include extraction and categorization of DNA, RNA and proteins from the tissues in question. Macrodissection of tissue to increase the proportion of tumor to nontumor tissue may also be utilized.
Biorepositories depend on the delivery of high quality annotated tissues to researchers. In order to accomplish this goal, QMSs and associated QCs are used to validate the quality and consistency of the tissues being distributed.