Guidelines in the Interim Use of the Laboratories of the National TB Control Program as COVID-19 Testing Laboratories Performing Rapid PCR Testing for SARS-CoV-2

April 18, 2020

DOH DEPARTMENT CIRCULAR NO. 2020-0187

 

Administrative Order No. 2020-0014, titled Guidelines in Securing a License to Operate a COVID-19 Testing Laboratory in the Philippines, was issued last April 7, 2020, to have more laboratories capable of detecting Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2), the causative agent of COVID-19. As of April 18, 2020, there are 17 licensed COVID-19 testing laboratories, using real time Reverse Transcriptase Polymerase Chain Reaction (rRT-PCR), with a combined daily output of 3,789 tests.

Latest data show that there are now 6,087 confirmed cases, with 516 recoveries and 397 deaths. However, 8,000 tests will have to be done daily to get a more accurate projection of infected individuals, making the current daily output 53% off from the target.

Different strategies, from having more licensed COVID-19 testing laboratories to extending the hours of operation of the licensed COVID-19 testing laboratories, have been considered to increase the daily test outputs. With the recent FDA approval of a Rapid PCR Tests for SARS-CoV-2, such as Xpert Xpress, which can be performed in a GeneXpert Instrument System, attention has turned to the culture laboratories of the National Tuberculosis (TB) Control Program which has this functional system in place. The System, with its self-contained cartridges, is semi-automated, so that results can be obtained in 45 minutes to an hour.

Hence, the Laboratories of the National TB Control Program are being tapped to be COVID-19 testing laboratories.

GENERAL GUIDELINES:

1. COVID-19 testing shall also be done in the Laboratory of the National TB Control Program which shall be duly licensed by DOH as a COVID-19 testing laboratory performing Rapid PCR Testing for SARS-CoV-2.

2. A DOH licensed COVID-19 testing laboratory performing Rapid PCR Testing for SARS-CoV-2 shall cater exclusively to COVID-19 testing.

3. All the standards and requirements in A.O. 2020-0014 shall apply to a COVID-19 testing laboratory performing Rapid PCR Testing for SARS-CoV-2, except for the following:

a. Personnel Complement and Required Trainings (details in Annex A — Assessment Tool for Licensing a COVID-19 Testing Laboratory Performing Rapid PCR Testing for SARS-CoV-2)

b. Physical Plant (Annexes B1 and B2 — Prototype/Reference Plan and Floor Plan Checklist of a TB Reference Laboratory performing Rapid PCR Testing for SARS-CoV-2)

c. Equipment, reagents and supplies (Annex A — Assessment Tool for Licensing a COVID 19 testing laboratory Performing Rapid PCR Testing for SARS-CoV-2)

d. The teams from HFSRB or CHD-RLED together with RITM or its designated 3rd party assessor shall conduct inspection of the said laboratory.

4. The DOH-LTO for a COVID-19 testing laboratory performing Rapid PCR Testing for SARS-CoV-2 shall only be issued upon full compliance to the standards and requirements set forth by HFSRB and RITM.

5.  The DOH-LTO for a COVID-19 testing laboratory performing Rapid PCR Testing for SARS-CoV-2 shall be valid for 3 months.

6. An evaluation shall be done after 3 months to determine if an extension in the validity of the DOH-LTO is warranted.

For immediate implementation and strict compliance.

By Authority of the Secretary of Health:

(SGD.) MARIA ROSARIO SINGH-VERGEIRE, MD, MPH, CESO IVOIC-Undersecretary of Health

ANNEX A

Assessment Tool for Licensing a COVID-19 Testing Laboratory Performing Rapid PCR Testing for SARS-CoV-2 Assay

ANNEX B1

COVID-19 Testing Laboratory Performing Rapid PCR Testing for SARS-CoV-2 Assay

ANNEX B2

Checklist for Review of Floor Plans