On May 23, 2020, the PA Department of Health (DOH) revised its guidance for ambulatory surgical facilities (ASFs) to require ASFs that intend to provide COVID-19 testing to patients and staff to hold the appropriate CLIA certification and state laboratory permit to perform such testing.

For specific information on what CLIA certification is required, please see the DOH’s guidance on COVID-19 lab testing here: https://www.health.pa.gov/topics/Documents/HAN/2020-PAHAN-505-05-06-UPD-Laboratory.pdf

The guidance also requires each ASF that has not obtained the requisite CLIA certification and approval from the state Bureau of Laboratories to contact the Bureau as soon as possible by email at RA-DHPACLIA@pa.gov with a brief description of the ASF’s intended testing plan and its current permit/CLIA information.

The guidance notes that an ASF does not need to have its own laboratory to test patients and staff as part of its screening procedures.  An ASF is also permitted to utilize a commercial laboratory to conduct the testing.

This Firm has independently confirmed with the DOH that the revised guidance does not require an ASF to have such testing arrangement in place prior to re-opening to perform elective procedures, provided that the ASF has determined that it is able to do so without jeopardizing the safety of patients and staff or the ASF’s ability to respond to the COVID-19 emergency.

The DOH reminds ASFs that laboratories must report all COVID-19 testing results, whether positive or negative, to the DOH’s electronic surveillance system, PA-NEDSS.  ASFs with laboratories that will test patients and staff for COVID-19 must comply with the reporting regulations.

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