CBR Reactivation Plan

Restrictions to CBR Returning to Normal Operations

  1. State restrictions
  2. University restrictions
  3. Volume of COVID-19 work
  4. Deployed staff, furloughed staff, or RIF
  5. Social distancing
  6. Additional personal protective equipment (PPE) requirements
  7. Training requirements (for pandemic and post-pandemic working conditions)
  8. Availability of supplies, including PPE
  9. Sickness, fatigue
  10. Availability of courier services

Guiding Principles for Work Prioritization

  1. Support of strategic enterprise activities
  2. Criticality of care for patient population (e.g. cancer, pregnant women) where studies will enroll participants at time of clinic visits
  3. The complexity of the study in terms of kits required, visit schedules, and historic enrollment rates
  4. Ability of technical staff to perform required job functions while maintaining safe spacing in the laboratories
  5. Availability of other cores working in partnership with CBR (e.g. MCRU)
  6. Availability of clinic and study team resources

Phases

Phase 0 – “COOP & Critical research capacity”

  1. Non-critical research activity is shut down.
  2. The CBR Continuity of Operations Plan (COOP) is activated. 
  3. Essential activities only.
  4. Up to three technicians are allowed in the laboratories at a time, under strict social distancing guidelines and with appropriate PPE.
  5. Lab functionality to support critical activities (e.g. freezer maintenance and automation).
  6. COVID-19-related research is a considered critical activity.  COVID-19 -related work includes accessioning, centrifuging, aliquoting, storing, and distributing COVID-19 samples. 

 
Phase 1 – “Stabilization”

  1. University Research Stabilization Phase 1
    1. Low risk laboratory research work can occur on-site with mitigation
    2. In-person human subjects research will not resume. 
  2. Number of technicians in laboratories determined by space and distancing requirements.
  3. CBR COOP is deactivated.
  4. COVID-19 biorepository-related work takes highest priority. 
  5. CBR will begin working with studies doing remote consenting, and consortium studies with enrollment sites which have eased human subjects research restrictions and use the CBR for biospecimen logistics and storage.
  6. The only non-COVID-19 sample processing will be for samples that must be processed immediately.  Everything else will be stored and processed as the CBR restores capacity.


Phase 2 – “CBR Pandemic Interim Capacity”

  1. After restrictions on in-person human subjects research have been lifted, CBR Phase 2 can begin.
  2. CBR is still functioning at a lower capacity due to
    1. Number of technicians in laboratories determined by space and distancing requirements OR
    2. Still managing high level of COVID-19 research-related work. 
  3. CBR will begin to resume regular business in a phased approach based on the Guiding Principles above.
  4. In Phase 2, the CBR will prioritize resuming studies in the following sub-phases:
    1. Studies that do not use CBR kits
    2. Studies use CBR kits, but do not rely on other cores (e.g. MCRU, CTSO)
      1. Studies with participants for whom treatment or encounter is essential (e.g. cancer, pregnancy)
      2. Precision Health studies & studies with simple logistics
  5. Regular sample processing will not resume. Samples requiring processing are stored for processing at a later date.


Phase 3 – “Pandemic Full Capacity”

  1. The CBR will reach Pandemic Full Capacity once:
    1. All techs have returned full time AND
    2. There is a manageable steady-state of COVID-19 related activities.
  2. The CBR will not be at regular operations due to:
    1. Continued need for social distancing.
    2. Delays in the supply chain.
    3. Changes to courier services.
  3. CBR regular turnaround times may be delayed.
  4.  At the start of this phase (Phase 3A), the CBR will:
    1. Resume remaining studies in the following sub-phases:
      1. Studies with participants in the ER/ICU areas
      2. Studies with complex logistics
      3. Studies that depend on other cores (e.g. MCRU, CTSO)
    2. Resume regular sample processing
      1. Evaluate and process the sample backlog
    3. Resume regular distributions (e.g. to the Advanced Genomics Core)
  5. After existing CBR studies have resumed, the CBR will finalize implementation of studies whose onboarding began prior to the research shut down but were not able to Go Live (“Ready Studies” Phase 3B).
  6.  After Ready Studies have started, the CBR will (Phase 3C):
    1. Evaluate and resume existing retrospective sample transfer projects
    2. Onboard new studies in a limited capacity.  The onboarding rate may be slower than normal and will prioritize studies aligned with institutional priorities, including meeting obligations for sustained funding.
    3. Evaluate requested workflow changes for existing studies.


Phase 4 – “Normal operations”

  1. CBR will remain in Pandemic Full Capacity until the University has reached Phase 4.  At this point:
    1. Social distancing is no longer a requirement
    2. Remote work is no longer required
    3. Large groups can gather
  2. Once returned to normal operations, the CBR will:
    1. Restore normal turnaround times
    2. Resume onboarding at full capacity
    3. Take on other new business
    4. Reinstate non-core work (e.g. ad hoc sample processing requests)

 

 

Questions?

Contact us at CBR.Requests@umich.edu or (734) 647-8809 

North Campus Research Complex, Building 60-1660, 2800 Plymouth Road, Ann Arbor, MI 48105

A list of Central Biorepository contacts is available in the Personnel Directory