title: Progressive Consent and Specimen Accrual Models to Address Sustainability: A Decade's Experience at an Oregon Biorepository.
abstract: BACKGROUND
  The Legacy Biorepository is a College of American Pathologists-accredited biorepository operating within a seven-hospital healthcare system, with a decade's experience in specimen accrual, storage, and distribution. While standardization of our practices through accreditation remains a priority, we along with others face challenges with regard to sustainability. Purposeful changes in our consent process, which we term "progressive consent," are expected to improve sustainability and operational flexibility while increasing our scientific impact.
  
  
  METHODS
  Until 2015, informed consent was performed primarily by biorepository staff at an estimated time of 1 hour per case. After a process improvement exercise, we successfully changed our informed consent process to a modified front-door model, with use of material and data for research as an opt-in or opt-out selection on the institutional patient informed consent form provided to surgery patients in the healthcare system. Successful implementation of this change required the engagement and participation of multiple stakeholders in healthcare system leadership, hospital administration, research, legal, regulatory, and patient care levels.
  
  
  RESULTS
  A modified front-door consent enabled us to collect an additional 38 specimens in the first two quarters of 2016, with a time commitment of 15.75 hours, a time savings per specimen increasing in Q2 over Q1. We estimate a potential savings of 43 hours in 2016. This progressive model allowed us to maintain our frozen sample collection while increasing the availability of paraffin-embedded tissue and bodily fluids. Augmenting our tissue collection added little expense per case (approximately half that of each frozen tissue aliquot) and increased the range of biospecimens collected.
  
  
  CONCLUSIONS
  Biorepository financial sustainability is a critical issue. Thorough evaluation and modification of existing procedures and collection models, as well as cost recovery initiatives, can translate into savings. Sustainability, process improvement, and scientific impact broadly overlap and continue to require operational critique and implementation of strategic changes.
authors.affiliation: Legacy Biorepository, Legacy Research Institute , Legacy Health, Portland, Oregon.
authors.forename: John A
authors.initials: JA
authors.lastname: Ost
authors.affiliation: Legacy Biorepository, Legacy Research Institute , Legacy Health, Portland, Oregon.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Newton
authors.affiliation: Legacy Biorepository, Legacy Research Institute , Legacy Health, Portland, Oregon.
authors.forename: Duncan R
authors.initials: DR
authors.lastname: Neilson
authors.affiliation: Legacy Biorepository, Legacy Research Institute , Legacy Health, Portland, Oregon.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Cioffi
authors.affiliation: Legacy Biorepository, Legacy Research Institute , Legacy Health, Portland, Oregon.
authors.forename: P Ashley
authors.initials: PA
authors.lastname: Wackym
authors.affiliation: Legacy Biorepository, Legacy Research Institute , Legacy Health, Portland, Oregon.
authors.forename: R Serene
authors.initials: RS
authors.lastname: Perkins
mesh_terms: D018070:Biological Specimen Banks; D005629:Frozen Sections; D006801:Humans; D007258:Informed Consent; D008962:Models, Theoretical; D009922:Oregon; D016612:Paraffin Embedding; D013048:Specimen Handling / Q000379:methods*; D016707:Tissue Fixation
keywords: biorepository; consent; front-door model; process improvement; specimen; sustainability