MUNTINLUPA CITY—In light of the coronavirus pandemic, more hospitals and private laboratories have shown interest in setting up their own COVID-19 testing centers. To date, more than 90 laboratories have expressed their intention to obtain certification, but only a total of 56 applications have been submitted to the Department of Health (DOH). Of this number, 16 have already been certified to augment and expand the testing capacity of the Research Institute for Tropical Medicine (RITM).
According to RITM Director Celia Carlos, the results of the proficiency testing for the 16 certified laboratories have been impressive despite time restrictions. “Out of the sixteen laboratories that have been certified, two underwent a repeat of the proficiency tests, whereas the others got 100% marks on their first assessment. This paints a very encouraging picture of COVID-19 testing capacity and the accuracy of results in the Philippines,” she said.
Interested facilities must strictly adhere to the requirements indicated on the Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory (Administrative Order No. 2020-0014) released by the health department in April 7, 2020. RITM, as a crucial member of the DOH Assessment Team, has noted that the usual causes for application delays include non-compliance with facility and equipment standards, inappropriate workflows, and noncompliance to biosafety standards.
“We reiterate that the applicant facility must be a Biosafety Level 2 (BSL2) laboratory with specialized ventilation. To ensure accuracy of results, the laboratory must also have properly calibrated equipment such as real-time PCR machines and biosafety cabinets. It is also imperative that laboratory technologists are trained and certified in molecular diagnostic procedures and biosafety practices, and that the applicant facility has regularly-updated protocols including a biosafety manual for handling Risk Group 3 pathogens such as the SARS-CoV-2,” she added.
Currently, the Institute has reported that in the multistage process of laboratory assessment, 27% of the 56 applications received by DOH have proceeded beyond Stage 1, while 39 are in various stages of on-site inspection, requirements compliance, and proficiency testing.