Bulletin 20-3

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The AATB Physicians Council Issues Donor Screening and Deferral Recommendations to Tissue Bank Medical Directors Related to the Novel Coronavirus (2019-nCoV) Outbreak

Background information: Coronaviruses are a large family of viruses with some causing less-severe disease, such as the common cold, and others more severe disease described as Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

SARS- and MERS-associated coronaviruses (SARS-CoV and MERS-CoV) have been previously identified as the causing agents of SARS and MERS. However, the most recent outbreak of illness causing pneumonia in Wuhan, China is different from that seen in infections by coronaviruses that have been identified in the past. Earlier laboratory tests ruled out SARS-CoV and MERS-CoV, as well as influenza, bird flu, adenovirus and other common lung-infecting microorganisms.

The new virus identified as Novel Coronavirus (2019-nCoV) so far does not appear to be as deadly as SARS-CoV and MERS-CoV, but possible mutation and increased virulence may change the risk assessment.

Considering the rapid expansion of the outbreak to a current number of over 6,000 confirmed by PCR cases and published data showing possible person-to-person air-borne respiratory droplet mechanism of transmission, and

Considering the current number of 500 investigated cases in the United States with 5 confirmed 2019-nCoV cases and confirmed case clusters in Europe, and

Considering the most recent clinical, epidemiological and scientific data relating to 2019-nCoV, the AATB Physicians Council formed a designated Panel comprised of tissue bank medical directors and end-user clinicians with the objective to conduct a thorough assessment of the risk posed by 2019-nCoV and recommend specific measures pertaining to the processes of donor screening and donor eligibility determination designed to mitigate such risk.

As a result, until further data becomes available and until further notice, the AATB Physicians council recommends the implementation of the following donor exclusion criteria by AATB tissue bank medical directors:

   

AATB 2019-nCoV Donor Deferral for HCT/Ps

GUIDANCE to Tissue Banks and Tissue Bank Medical Directors

 

Donor exclusion for exposure to 2019-nCoV in last 28 days before donation

  • Travel to China (regardless of symptoms), or

  • Travel to other geographic area designated as area of active transmission by CDC* and (i) presentation of symptoms consistent with 2019-nCoV (e.g., unexplained fever, cough, diarrhea) or (ii) exposure link to suspected case patient while in the designated area; or

  • Close contact with a person who has confirmed 2019-nCoV infection

 

Donor exclusion for infection with 2019-nCoV, in the last 28 days before donation

  • Test positive for 2019-nCoV; or

  • Symptoms consistent with active 2019-nCoV infection (e.g., unexplained fever, cough, diarrhea) in a patient with suspected 2019-nCoV infection

 

* https://www.cdc.gov/coronavirus/2019-ncov/index.html

 

This Guidance is not intended to lead to permanent and/or longstanding changes to Standards, Appendices, or UDRAI, but is intended to provide guidance to tissue bank medical directors on implementing certain 2019-nCoV-related exclusion criteria based on travel, exposure and/or infection. Any specific adjustments to the donor screening and donor eligibility determination processes, including clinical judgement and decision making relating to specific cases, should be in the discretion of the tissue bank Medical Director.  

The AATB continues to monitor the situation and will provide its accredited institutional members with any new information as it becomes available.  

For additional information contact Roman Hitchev MD, AATB VP & Chief Science Officer at hitchevr@aatb.org