AABB is alerting member facilities to three important government actions with the potential to affect the transfusion medicine community.
Immediate Requirement of Reporting SARS-CoV-2 Test Results to CMS
The Centers for Medicare and Medicaid Services (CMS) today published an interim final rule with comment period (IFC) that takes effect immediately. The interim final rule establishes requirements for CLIA laboratories to report all COVID-19 test results to the secretary of Health and Human Services during the COVID-19 public health emergency (PHE). The regulations take effect immediately and apply to all types of certificates, including certificates or waiver, as well as certificates of accreditation. They also include antibody testing performed by blood centers, since that testing is intended to detect COVID-19.
In their current form, these regulations apply to COVID-19 testing performed by blood collectors, including antibody tests performed to identify possible COVID-19 convalescent plasma donors.
The rule also makes the failure to submit COVID-19 test results a condition-level deficiency subject to $1,000 civil money penalty for the first day of noncompliance and $500 for each subsequent day.
The IFC notes that reporting of test results should follow the June 4 guidance from CMS. An FAQ document for that guidance notes that reporting “…should occur within 24 hours of results being known or determined, on a daily basis, to the appropriate state or local public health department based on the individual’s residence.”
AABB is continuing to work with CMS to obtain clarity around these new regulations and on their impact on blood collectors and testing centers. At this time, the impact is unclear because blood collectors perform this testing in the context of a biological manufacturing process. AABB brought this issue forward to FDA, and FDA officials indicated their intent to address this with CMS. AABB is advocating with CMS to exclude blood centers from this ruling; if this is not possible, AABB will advocate for the new requirements to be minimally burdensome. The Association will provide updates as soon as they become available.
The impact on blood collectors is still unclear, since this testing is typically performed in the context of a biological manufacturing process. AABB brought the issue forward to FDA, and FDA officials indicated their intent to address this with CMS. In addition, AABB is advocating with CMS to exclude blood centers from this ruling. The Association will provide updates as soon as they become available.
For facilities using AABB as their CLIA provider, please note that these new regulations are being incorporated into the AABB assessment process. All AABB members should be aware that the IFC amends regulation 493.555, which now includes a paragraph (c)(6) requiring that, for the duration of the COVID-19 PHE, all accrediting organizations must notify CMS within 10 days after identifying a laboratory that fails to report COVID-19 test results as required.
Final Guidance on COVID-19 Convalescent Plasma
Today, the Food and Drug Administration published a new final guidance containing recommendations for the collection and use of COVID-19 convalescent plasma for emergency use. This action was expected following the approval of the emergency use authorization (EUA) for CCP on Aug. 23.
The recommendations address:
- Pathways for use of investigational convalescent plasma.
- Collection of CCP under the EUA.
- Collection of CCP under an IND.
- Support of randomized clinical trials that will not be impacted by the release of the EUA.
Most notably, the guidance addresses FDA’s approach to compliance that will support uninterrupted access to CCP for patients in need of treatment by permitting the use of the current inventory of investigational CCP collected prior to the EUA.
“FDA intends to exercise this discretion with respect to the IND requirements for the collection, shipment, and administration of investigational convalescent plasma for a period of 90 days following the issuance of this guidance document,” the guidance stated.
AABB will issue additional communication about this issue this week.