Clarification of the Operation of Multiple Laboratories at the Same Location and the Discontinued Use of the Term “Shared Laboratory” QSO-18-20-CLIA

Attention: Clinical Laboratories, Acute Care Hospitals, Critical Access Hospitals

Please share this announcement with the following:

  • Medical Director, Laboratory Services
  • Administrative Director and Managers, Laboratory Services

On July 20, 2018, the CMS/CLIA issued two memos regarding laboratories as noted above.

Key Points of Performance Specification Verification of Assays Authorized Under Emergency Use (EUA) QSO 18-19-CLIA:

Assays that have been issued an EUA by the FDA remain subject to the CLIA regulations. As required by CLIA regulation 493.1253(b)(1), the laboratory must verify performance specifications of the unmodified, FDA-cleared test system before reporting patient test results. In the event that there is not the usual number of positive specimens available for verification of the performance of the assay, it is still the responsibility of the laboratory director to ensure that verification procedures are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

In the event that the laboratory is using a CDC developed assay authorized for emergency use, the laboratory should follow any and all instructions provided by the CDC for verifying performance specification.

Key Points of Clarification of the Operation of Multiple Laboratories at the Same Location and the Discontinued Use of the Term “Shared Laboratory” QSO-18-20-CLIA:

The term “shared laboratory” has been discontinued and will no longer apply.

Multiple laboratories with separate CLIA numbers may operate at one location provided that each laboratory can demonstrate that it is operating as a distinct entity.

Multiple laboratories with separate CLIA numbers that operate at the same physical location and use the same testing personnel and equipment must:

  1. Keep all records (quality control, procedure manuals, competency documentation) separate and distinct and must clearly demonstrate that each laboratory is operating independently;
  2. Specify the hours of operation for each laboratory, which must be must be separate and distinct each laboratory; and
  3. Complete an online application for each waived or non-wavied CLIA certificate to be surveyed.

Are any AOA/HFAP Standards affected by this change?
There are no AOA/HFAP Standards affected by these two memos.

Click here to read QSO 18-19-CLIA

Click here to read QSO 18-20-CLIA

Effective date: Immediately

Questions? Please contact us at info@hfap.org.