Cape Town – A Claremont laboratory has received a notice of immediate cessation of Sars Cov-2 testing due to non-compliance, says its coronavirus tests are now being processed at a sister laboratory of the Observatory.
In a Jan. 7 opinion from the Director General of the Department of Health (DOH), Dr Sandile Buthelezi, said: “Your laboratory has not submitted a request for minimum requirements sent to all laboratories intending to perform diagnostic tests for Sars Cov-2. This was communicated to you in October 2020 by the team which is carrying out an assessment and pre-examination of all the laboratories.
“Although reminders and follow-up have been done with your lab, you have not sent any documents to date.”
“Therefore, your lab is not recommended to provide Sars Cov-2 testing on behalf of any of the NHLS labs, as it is necessary.”
The department advised the lab to go through the selection process conducted by the National Department, and until then the facility was prohibited from conducting Sars Cov-2 testing.
Failure to comply with this advice constitutes a violation of Regulation 178 of the 2003 National Health Act.
Health department spokesman Popo Maja confirmed on Wednesday that the notice had been sent to the lab.
In a statement, however, Hamadi Lab management said it was in full compliance with all regulations until new regulations were brought to their attention last Friday.
“The management of Hamadi Lab would like to reassure all our customers that contrary to what was written in the letter; Hamadi Molecular Laboratory was in full compliance with all regulations until the new regulations were brought to our attention last week on Friday.
“These new rules are (a few) few points that the national DOH has implemented to regulate all laboratories performing Sars-COV-2 PCR tests.”
Management said the lab submitted all required information to the DOH Covid-19 registration team on Tuesday.
“The team will go through the assessment steps … then issue our permit.”
“There is nothing wrong with Hamadi Lab’s processes, but the new required documentation must be submitted to the authority for their registration.
“During this time, nothing has changed in our operation; our PCR tests will be carried out in our twin laboratory at the Observatory since they have already received their new license; Please note that this will not affect our TAT and once our new license is issued we will resume PCR testing. “
Provincial health department spokesman Mark van der Heever said neither their department nor the national health laboratory services had used Hamadi to test samples for Covid-19.
“Their ban by the national health ministry from doing Covid testing has no impact on the department’s testing capacity,” Van der Heever said.