October 27, 2021
AABB, as part of a coalition of organizations, asked officials at the Centers for Medicare and Medicaid Services (CMS) to explicitly permit the delegation of the semi-annual competency requirement specified in 42 CFR 493.1451(b)(9).
Current regulations specifically permit the director or technical supervisor to delegate to the general supervisor the annual evaluations of testing personnel but are silent on the delegation of the semi-annual competency evaluation. In previous communications with AABB, CMS representatives stated that the agency has allowed the general supervisor to perform the semi-annual evaluation when delegated by the technical supervisor. However, CMS recently indicated that the technical supervisor must directly observe the semi-annual assessment of competency.
In the letter, AABB and its partner organizations explained their view that this conflicting guidance on the delegation of the semi-annual evaluation is confusing and overly burdensome. Additionally, they feel it leaves the regulated community unclear about how to comply with the regulations.
Since the semi-annual evaluation is the same as the annual evaluation, the organizations encouraged CMS to explicitly permit the technical supervisor to delegate both assessments to the general supervisor. Furthermore, they believe that by modifying its most recent interpretation of the semi-annual competency assessment and explicitly permitting the technical supervisor to delegate this function to the general supervisor, CMS can help blood centers ameliorate workforce challenges resulting from the ongoing COVID-19 public health emergency.
AABB encourages members with questions or comments to contact firstname.lastname@example.org.