Through a collaboration with NorDx, clinical samples that have research value and that would ordinarily be discarded following clinical diagnostic testing, are retained and distributed to internal investigators and external BioBank collaborators.
The samples and associated clinical data obtained from EPIC, the MaineHealth electronic health record (EHR), are distributed under the Maine Medical Center BioBank’s Institutional Review Board (IRB) approved protocol. All samples and data are deidentified (i.e. stripped of all patient identifiers including name, accession number, etc.) and assigned a randomly generated code number prior to distribution. Following sample and data distribution, the link between patient identifiers and the code number is destroyed in the BioBank’s inventory database. Because the link is destroyed, patient informed consent is not required in order for these samples to be used for research according to Federal Regulations 45 CFR 46.101b and 46.102. However, because the link is destroyed, additional clinical data beyond what was originally requested cannot be obtained following distribution of the samples and data.
NorDx, located at 301 US Route 1 in Scarborough, performs diagnostic testing on over 1,000 biospecimens collected daily throughout the MaineHealth network of hospitals. Prior to diagnostic testing, blood samples are processed using the fully automated COBAS 8100 diagnostic equipment. Serum or plasma that is removed once testing needs are met is aliquoted, stored and distributed for research. The retrieval of remnant samples is based on the clinical diagnostic test that the sample was collected for. For example, if an investigator is interested in a cohort of samples from cardiology patients, the COBAS 8100 would be programmed to retain a portion of the serum from the blood sample that was collected for a test ordered to assess cardiac function.
Other body fluids such as urine, cerebral spinal fluid, bronchoalveolar lavage and stool samples may also be collected and reserved for research by NorDx staff in the cytology and microbiology laboratories once diagnostic sample testing needs have been met.
The remnant sample program, which was approved by the IRB in 2017, accelerates research by efficiently providing cohorts of samples fully annotated with clinical data and with inclusion and exclusion criteria as specified by investigators, thereby eliminating delays due to prospective collection of samples. This program also eliminates the need for phlebotomy for collection of samples for many studies which is of benefit to patients.