This is an update from the CAP’s accreditation programs based on clarification received from the Centers for Medicare & Medicaid Services (CMS) on:
- Remote review of slides, data, and images by laboratory professionals
- Quality control (QC) for COVID-19 testing
The following applies only to testing performed during the COVID-19 health care emergency:
Expanded Provisions for Remote Review and Reporting
- On March 26, 2020, the CMS issued a memorandum QSO-20-21-CLIA expanding its enforcement discretion to adopt a temporary policy that will allow pathologists to work remotely to report laboratory data/slides/images under specific conditions during the COVID-19 health care emergency.
- With this temporary change, other types of laboratory professionals, such as cytotechnologists, toxicologists, and cytogeneticists may also review slides/data/images at a temporary location without obtaining a separate CLIA number under the same conditions.
These provisions offer flexibility to help your laboratory reduce personnel exposure risk and ensure testing capacity for the continuity of patient care.
Clarified QC Options for COVID-19 Testing
- Laboratories may perform external quality control at the frequency defined in the manufacturer’s instructions for emergency use authorization (EUA) COVID-19 test kits.
- An individualized quality control plan (IQCP) is not required if external QC is performed less frequently than defined in the default CLIA regulations (ie, two levels of daily external QC).
- External QC may not be performed less frequently than defined in the manufacturer’s instructions.
The CAP requires that laboratories performing external QC less frequently than the default CLIA frequency develop and implement an IQCP for COVID-19 test methods with an internal quality control process; however, it is not required during the COVID-19 health care emergency. Visit the CAP’s IQCP Toolbox for resources to develop an IQCP by logging into e-LAB Solutions Suite and searching for “IQCP Toolbox.”
With the rapidly evolving testing environment and regulatory issues related to the COVID-19 health care emergency, the CAP is updating resources daily:
Questions? Contact us at 800-323-4040 or email@example.com.