April 2, 2020
The AATB Physicians Council formed a standing Panel, hereto known as PC Subgroup, to provide on-going surveillance of the emerging SARS CoV-2/COVID 19 situation. This PC Subgroup has been and will continue to collect data in order to assess, in real-time, the recommendations for our members for donor evaluation with the objective to protect recipients and recovery personnel, to the extent possible. Refer to previously issued Bulletins on the subject of COVID-19 (Bulletin No.20-3 of January 31, 2020, Bulletin No.20-7 of February 25, 2020, Bulletin No.20-8 of March 4, 2020, and Bulletin No.20-9 of March 14, 2020).
This information will continue to be provided through Bulletins and by shared communications with the Physicians Council and tissue bank medical directors.
Update on Travel Recommendations:
On March 29, 2020, the CDC issued a Domestic Travel Advisory for New York, New Jersey, and Connecticut. In addition to the NY, NJ, and CT travel advisory, cases of coronavirus disease (COVID-19) have been reported in all states, with some areas experiencing sustained community spread of the disease.
The PC Subgroup met to discuss the relevancy of continuing to use the travel-based exclusion/deferral criterion. As a result of a thorough evaluation and discussion, the PC Subgroup unanimously agreed that the criterion might no longer be applicable but continues to recommend that each tissue bank medical director may consider travel-based criteria at their discretion and with information that may be available on a potential donor in regards to travel, residency in identified high community spread areas or close contact with individuals that may be considered as a persons under investigation1 (PUI). In this process, medical directors may refer to the CDC on areas at risk for transmission and the latest travel advisories, both international and domestic, on a case-by-case basis as deemed necessary.
By a unanimous vote, the PC Subgroup also recommended to continue to retain clinical criteria. However, considering the changing situation with using travel-based criteria and the non-specific (if any) symptomatology of COVID-19, medical directors are advised to seek and evaluate available medical records for all sources of clinical data, including seemingly unrelated signs and symptoms, imaging studies, epidemiological circumstances, differential diagnosis notes and documented consultations, and others. It is understood that some cases will not be detected by clinical criteria, as a significant proportion of individuals have asymptomatic infection.
Update on Testing:
The PC Subgroup assessed the prospects for mitigating the risk relating to COVID-19 through laboratory testing of potential donors. Testing is currently available through a polymerase chain reaction (PCR) test of clinical samples, usually obtained through oropharyngeal or nasopharyngeal swab. These PCR platforms are diagnostic tests, i.e., not optimized for donor screening, and have not been validated for cadaveric samples. After a thorough discussion, considering possible risks and benefits, the PC subgroup has voted to recommend lab testing as part of donor screening using PCR testing obtained via swab, if available.
The PC Subgroup is monitoring the development and introduction of various new tests under the FDA emergency use authorization, some of which may be suitable for the purposes of donor screening. One of the testing platforms recently approved by the FDA may provide tissue banks with the option of rapid, portable point-of-care SARS-CoV-2 detection producing results on-site allowing for pre-recovery assessment. In addition, a test on serum or plasma validated for cadaveric donor screening may also be in development. The PC Subgroup will keep the entire Physicians Council informed about such new testing options as they become available.
During the preparation of this Bulletin for publishing, on April 1, 2020, the FDA issued the following statement:
FDA is aware that some HCT/P establishments in the US are considering additional donor screening and testing measures in response to the COVID-19 outbreak.
At this time, FDA does not recommend establishments use laboratory tests to screen asymptomatic HCT/P donors. Based on available information, it appears that SARS-CoV2 has only been detected in blood samples of a small percentage of severely ill patients.
The HCT/P establishment’s responsible person must evaluate a prospective donor and determine eligibility (21 CFR 1271.50). Based on the limited information available at this time, establishments may wish to consider, whether, in the 28 days prior to HCT/P recovery, the donor
Considering that the FDA recommendation to not use laboratory tests “to screen asymptomatic donors” does not appear to apply to symptomatic donors, it would be up to the medical director responsible for donor eligibility determination to choose the risk mitigation methods and criteria for donors presenting with symptoms that may be attributed to COVID-19.
Recovery Personnel Safety
The PC Subgroup is also initiating an assessment and discussion about recovery personnel safety relating to COVID-19, including but not limited to, risks for personnel getting infected from an undiagnosed donor with COVID-19, risk for tissue contamination from asymptomatic personnel, as well as the role of the medical director in the process of developing personnel policies relating to COVID-19.
Medical Director’s Discretion
As previously emphasized, the ultimate selection of risk-mitigation criteria pertaining to COVID-19, e.g., travel evaluation, symptomatology, exposure, close contact, infection status, and testing for COVID-19, is in the sole discretion of the medical director of the tissue bank responsible for donor eligibility determination as long as the intent of relevant standards, e.g.. D4.120, D4.150, F1.120 and Appendix II is met.
AATB will inform its members if any material changes require additional measures. For additional information, please contact the AATB Executive Office, Dr. Roman Hitchev, AATB VP & Chief Science Officer.
1Person under Investigation (PUI): Refer to CDC Criteria to Guide Evaluation of PUI for COVID-19 - https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html