MUNTINLUPA CITY – Due to the pressing need to expand the country’s testing capabilities to diagnose suspected COVID-19 cases, the Department of Health-Research Institute for Tropical Medicine urges interested laboratories and hospitals to adhere to the multistage process for COVID-19 lab assessment.
At present, groups are advised to write a letter of intent addressed to OIC Undersecretary Maria Rosario Singh-Vergiere of the Department of Health (DOH) Health Regulation Team at firstname.lastname@example.org.
Upon receipt of the letter, DOH will send a self-assessment tool designed by RITM. This serves as an initial evaluation to check the readiness of a laboratory to conduct the complex polymerase chain reaction (PCR) testing of suspected COVID-19 cases. A DOH Assessment Team will review the tool and provide inputs on which areas of improvement the interested laboratory should prioritize.
“An on-site visit will be arranged to check the laboratory. An assessment of gaps, technical, and safety recommendations will be provided,” said RITM Director Celia Carlos to describe the primary parameters measured in the initial stages of laboratory assessment: design and layout of the facility; workflow; equipment; trained personnel; logistics and supplies; management system; and safety controls among others.
Once recommendations have been provided, the laboratory must submit evidences of their compliance before they could be given the go signal to proceed to the next stage, which involves proficiency testing (PT).
RITM will provide a PT panel that consists a set of unknown samples. The laboratory technologists of the applicant laboratory must then test these samples on PCR. The results of their testing will be the basis for determining whether their facility and staff complement is capable to correctly and accurately test for COVID-19.
If successful, the DOH Assessment Team will recommend the laboratory to proceed with COVID-19 testing. The laboratory will then submit the first five (5) positive samples to RITM for confirmation. If the results are in agreement with RITM’s, the laboratory can commence with COVID-19 testing independently.
As the National Reference Laboratory for emerging and re-emerging infectious diseases, RITM will regularly conduct proficiency testing to ensure and maintain the high-quality performance of independent laboratories.
Applicants wishing to obtain training on PCR testing for COVID-19 can avail of said training from RITM and other laboratories already certified to test for COVID-19.