RITM suspends Pampanga private laboratory over discrepancies in COVID-19 test results

CITY OF SAN FERNANDO, Pampanga – The Research Institute for Tropical Medicine (RITM) has temporarily suspended a private laboratory here from conducting reverse transcription-polymerase chain reaction (RT- PCR) testing for coronavirus disease (COVID-19) after the results of its probe showed major violations that led to discrepancies in swab test results in the province.
 
The suspension of Green City Medical Center Molecular Pathology Laboratory took effect last Friday, September 25, which was disclosed during the Sangguniang Panlalawigan (SP) Committee on Health meeting held at the session hall.
 
“The laboratory should temporarily defer from SARS CoV 2 Real-Time PCR testing until specific recommendations to address major issues/violations are complied with,’’ RITM said in its eight-page report that was thoroughly discussed during the meeting with SP members.
 
Green City was also recommended to undergo laboratory assessment and proficiency testing on SARS-CoV2, the virus that causes COVID, after 30 days, and to require their laboratory staff to attend hands-on training for RT-PCR detection provided by RITM within a month. The date has yet to be scheduled.  
 
The RITM investigation cited four major violations that resulted in its decision to defer accreditation for RT-PCR testing of COVID-19 cases for the said laboratory. These were SARS-CoV 2 viral RNA contamination – areas or surfaces used for swab testing were contaminated; release of results were based on an invalid run; poor traceability of records; and biosafety concerns.
 
To reduce the risk for contamination, RITM recommended for  Green City to strictly implement regular surface decontamination protocol or compartmentalization of clean and dirty areas; purchase specimen racks and autoclave for post-PCR wastes (including PPEs, consumables used in the post-PCR); reduce the risk for data integrity and data security breach by adopting a lab information management system; and ensure completeness of required information in the Case Investigation Form (name, age, birthdate, disease, reporting unit, address, contact number, symptoms, date of onset of illness, history of exposure, travel history).
 
Governor Dennis Pineda earlier requested RITM, a state research hospital under the Department of Health (DOH), to investigate the integrity of results of COVID-19 swab tests being conducted in the province after reports of mounting number of positive cases turning up as negative in just a matter of days.
 
“Gusto kong siguraduhin na tama ang mga lumalabas na results sa mga labs natin. Kung gagastos ang Kapampangan, gusto ko hindi masasayang ang pera nila. Mahal magpatest, at least man lang yung resulta ay tama,’’ the governor said.
 
The probe centered on three COVID-19 testing laboratories in Region 3 – Green City, Jose B. Lingad Memorial General Hospital (JBL) and Philippine Red Cross – Clark.
 
RITM also made recommendations for improvement of testing in JBL and PRC-Clark. These included improvements on data management and contamination control.
 
RITM pressed these testing centers to store positive control samples from PCR kits to sample preparation area freezers instead of reagent preparation freezers to minimize risk for “amplicon” contamination. An amplicon is a piece of  DNA or RNA that is the source and/or product of amplification or replication events.