Cape Town - A Claremont laboratory issued with a notice to immediately cease Sars Cov-2 testing as a result of non-compliance, says its coronavirus tests are now being processed at a sister laboratory in Observatory.
In a January 7 notice by the Department of Health (DOH) director-general Dr Sandile Buthelezi, said: “Your laboratory has not submitted an application for minimum requirements sent to all laboratories intending to conduct diagnostic testing of Sars Cov-2. This has been communicated to you as early as October 2020 by the team that is conducting an assessment and pre-screening of all laboratories.
“Although reminders and follow-up were done with your laboratory, you have not sent any documents to date.”
“Your laboratory is therefore not recommended to provide any Sars Cov-2 testing on behalf of any of the NHLS laboratories as it is required.”
The department advised the lab to subject itself to the screening process conducted by the national department, and until then, the facility was barred from conducting any Sars Cov-2 testing.
Failure to comply with the notice will be in breach of the Regulation 178 of the National Health Act, Act 2003.
Health department spokesperson Popo Maja on Wednesday confirmed the notice was issued to the lab.
In a statement, Hamadi Lab management however said they were fully compliant with all regulations until new regulations were brought to their attention last Friday.
“Hamadi Lab management would like to reassure all our clients that contrary to what has been written in the letter; Hamadi Molecular Laboratory was fully compliant to all regulations until the new regulations were brought to our attention last week Friday.
“These new rules are (a) few points that the national DOH implemented to regulate all laboratories conducting the Sars-COV-2 PCR testing.”
Management said the lab had submitted all required information to the DOH Covid-19 registration team on Tuesday.
“The team will follow the assessment steps… then issue our permit.”
“There is nothing wrong with Hamadi Lab processes, however the required new documentation needs to be submitted to the authority for their recording.
“Meanwhile, nothing has changed in our operation; our PCR tests will be conducted at our sister lab at Observatory since they have received their new permit already; please note that this will not affect our TAT and once our new permit is issued we will resume the PCR testing again.”
Provincial health department spokesperson Mark van der Heever said neither their Department nor the National Health Laboratory Services made use of Hamadi for testing samples for Covid-19.
“Them being precluded by the National Department of Health from doing Covid testing has no impact on the department's testing capacity,” Van der Heever said.