Feds cite multiple deficiencies at two COVID-19 testing companies with pop-ups across suburbs
Federal regulators found sloppy practices at two additional Chicago-based COVID-19 testing companies serving thousands across the region.
U.S. Centers for Medicare and Medicaid Services inspectors found serious deficiencies that included improper labeling and handling of samples at facilities operated by O'Hare Clinical Labs and Northshore Clinical Laboratories or their subcontractors, CMS records showed Thursday.
The CMS scrutiny was triggered by complaints from consumers about pop-up clinics because of delays in getting test results or no results at all. State authorities are also investigating.
"We are looking into the complaints we have received, including by contacting those consumers to obtain more information," said Annie Thompson, spokeswoman for Illinois Attorney General Kwame Raoul.
Northshore handles testing for a number of suburban school districts, including Downers Grove Elementary District 58 and Wheeling Township Elementary District 21.
A CMS report based on site visits to certain Northshore facilities cites inadequate training to take nose swabs, storing test kits improperly, failing to use a timer for test strips, not keeping patient records, leaving patient records out in the open, sending duplicate results and entering information inaccurately into the system.
When it came to analyzing samples, proper procedures weren't always followed nor were controls established to catch errors in test results, CMS concluded. The director of one lab lacked the required medical experience and state certification, CMS found.
At a Northshore off-site testing location at a grocery store in Grayslake, the setup "did not have any barrier or screen to provide confidentiality" for patients, a CMS surveyor said.
Tubes with test samples were found in one shipping box "not labeled with any patient name or any other type of identifying information," records showed.
At O'Hare Clinical Labs, CMS inspectors found in some locations: patient specimens weren't properly identified or lacked names, a subcontractor was unauthorized, and one testing site had "no visible water supply," no light, no refrigerator for supplies, and no thermometer to ensure proper storage of test supplies and specimens.
A CMS official explained that when laboratories are found to be noncompliant with regulations, the lab is given an opportunity to respond and make corrections. If the lab fails to follow through, sanctions can occur.
Northshore Clinical Laboratories and O'Hare Clinical Labs did not respond to requests for comment.
Northshore Clinical Laboratories is not associated with NorthShore University HealthSystem, and O'Hare Clinical Labs is not associated with O'Hare International Airport.
This isn't the only pop-up test site issue. The COVID Center for Control, which also has numerous suburban locations, recently suspended operations so complaints about delays, missing and inaccurate tests could be investigated.
A lawsuit filed by Minnesota's attorney general stated Doctors Clinical Laboratory, which is affiliated with the COVID Center for Control, has billed the federal government about $113 million for "allegedly uninsured patients."