Lab Network QAP: Ensuring quality COVID-19 tests for all Filipinos

RITM was the first, and for a time, the sole COVID-19 testing facility in the country. The Institute led the capacity building of various labs in the country to help expand the national testing capacity; and is now implementing the Quality Assurance Program (QAP) for the COVID-19 PCR Laboratory Network. 

Ah, yung ospital ng mga nakakagat ng aso.”
“Facility for laboratory training courses”
“Research center for infectious diseases”
“Yung pagawaan ng panturok sa nakagat ng ahas”

Depending on who you ask about the Research Institute for Tropical Medicine (RITM), you’ll get varying answers similar or close to these statements. You might be wondering whether this is just a misunderstanding as one answer is far too different from the others—it’s not.                                                               

Established in 1981, the small Institute situated in what used to be the secluded hills of Alabang, Muntinlupa is a specialty hospital, vaccine manufacturing facility, training center, research facility, and home to 18 National Reference Laboratories (NRLs). When asked, people answer based on what RITM capacity they were dealt with—prior to the COVID-19 pandemic, that is.

Nowadays, RITM tends to more often come up in conversations related to COVID-19 pandemic and the government’s response. Interestingly enough, these discussions seem to happen more frequently within the halls of the Philippine senate and congress, and sometimes even from the country’s highest authority. Most recently, RITM launched the Quality Assurance Program for the COVID-19 PCR Laboratory Network, mandating all licensed testing facilities to regularly subject their facilities and processes to the Institute’s scrutiny. 

This begs the question, what happened in the last two years that catapulted RITM to new heights of relevance and public recognition?    


Empowering more laboratories

When the coronavirus disease reached Philippine shores, almost every sector but health was paralyzed. Hospitals scrambled to shift operations and grapple with the mounting challenges of limited isolation capacity, insufficient manpower, and depleting resources among others.

RITM had to hold back many of its programs and services to prioritize delivery of its mandate as a specialty hospital and the national reference laboratory for emerging and re-emerging infectious diseases.    

As an infectious disease specialty hospital with a capacity of 40 beds (and even less for isolation), RITM took to managing the more severe cases of COVID-19 during the onset of the pandemic. While the number of patient admission wasn’t much when compared against bigger hospitals, the Institute has contributed—and continues to contribute—a lot to pandemic response in many other ways.

For one, RITM doctors are recognized as among the country’s leading experts on infectious diseases and outbreaks. As such, they were tapped to join various technical working groups (TWGs) chaired by the Department of Health (DOH). These TWGs formulate and review protocols for the clinical management of COVID-19, which are eventually cascaded for implementation of all health facilities nationwide.   

Simultaneously, the Institute’s laboratory experts are also doing some serious heavy-lifting.

Back in January 2020, RITM was the only facility in the country with a laboratory recognized by the World Health Organization (WHO) to be capable of detecting SARS-CoV-2 (the virus causing coronavirus disease). The Institute became the first, and also for a time, the sole SARS-CoV-2 confirmatory testing laboratory in the Philippines.

With its own testing lab, the Philippines no longer needed to send samples of suspected cases to laboratories abroad and wait for weeks to receive confirmation. This significantly reduced the turnaround time for the test results which were integral in guiding medical experts in managing patients, and pivotal in informing the policies implemented across all sectors.

With its laboratory protocols and systems for COVID-19 testing firmly set, RITM was then able to start taking on more roles to assist in efforts to further expand the national testing capacity.

Early in March 2020, RITM commenced training other laboratories on the molecular diagnosis of SARS-CoV-2. Starting with successfully capacitating five sub-national laboratories, the ripple it created spread wide enough to lead to what we now know as the COVID-19 PCR Laboratory Network.

With the release of the DOH guidelines for securing a license to operate COVID-19 testing facilities in April 2020, RITM was formally inducted as a member of the laboratory assessment team led by the DOH Health Facilities and Services Regulatory Bureau (HFSRB).

Apart from conducting training for laboratories, the Institute is also put in-charge of the technical evaluation of reagents and diagnostic kits, and maintaining a quality assurance program for the Lab Network.

This means that for all brands of reagents and COVID-19 diagnostic kits applying for the Food and Drug Authority (FDA) accreditation to legally enter the Philippine market, they would have to first meet the validation

and evaluation standards of the Institute. RITM has since validated eight (8) different COVID-19 testing kits. At present, there is an ongoing evaluation for five (5) other kits. The status and results for each kit evaluation conducted are made publicly available on the Institute’s official website.     

On 06 September 2021, RITM formally launched the Quality Assurance Program (QAP) for the COVID-19 PCR Laboratory Network on. The virtual orientation was attended by 440 laboratory managers and representatives of all licensed public and private COVID-19 PCR testing labs in the country.

With all the COVID-19 testing, kit evaluation, laboratory assessments, and training activities simultaneously and continuously performed by RITM throughout the last two years, it is understandable how one can get the impression that COVID-19 response is the Institute’s sole mandate.


Building a culture of quality standards

Now there might still be a small part of you wondering why RITM has become the authority on quality assurance for COVID-19 testing, given that the Institute is also relatively new to this. The answer lies in the many years that the Institute has been quietly championing quality assurance in the lab as the administrator of the National External Quality Assurance Scheme (NEQAS) for various infectious diseases for over two decades now.

Home to almost all the National Reference Laboratories (NRLs) for infectious and tropical diseases in the country, RITM NEQAS is the overseer ensuring that laboratories across the Philippines are providing reliable and accurate results for diseases like polio, measles, malaria, dengue, and influenza to name a few. To date, there are 4,029 laboratories nationwide currently enrolled in the NEQAS.

Meanwhile, the Quality Assurance Program (QAP), developed in collaboration with the Department of Health and the World Health Organization, serves to ensure that all DOH-licensed COVID-19 PCR testing laboratories are capable of providing accurate and reliable results and that error-related risks are reduced.

The importance of such a program is clearly encapsulated in the words of RITM Director Celia Carlos, “Testing is one of the pillars of our country’s pandemic response. At the national level, test results inform the government on the effectiveness of its COVID-19 response measures, identifies where cases are found, and what strains exist or are emerging. The network’s accumulated data provide direction as to what interventions to take. With this considered, it is clear that we all have an obligation to ensure the reliability, accuracy, and timeliness of all reported results.”

Under the QAP, laboratories shall report the daily status on their identified key performance indicators and laboratory quality indicators in the Laboratory Quality Management System (LQMS). This will facilitate the closer monitoring of their testing activities and output, thus allowing the DOH to provide proper and timely interventions when necessary.

Simply put, it is the Institute’s responsibility to appraise and guide how COVID-19 laboratories are conducting their testing; identify points of improvement, and ensure that they take necessary steps to rectify lapses and permanently avoid recurrence.

While the need for setting up and accrediting more COVID-19 testing laboratories that meet the national testing demand must take priority, it is equally important to establish a technical and operational governing body for the lab network, and a mechanism for ensuring the generation of quality output across the nation.

Participating in the QAP has now become a prerequisite to the laboratories’ License to Operate renewal every year. Under this program, all licensed COVID-19 PCR laboratories are mandated to participate and pass the annual laboratory Proficiency Testing (PT) administered by RITM. Each lab will be rated with Quality Stars based on their overall laboratory assessment performance, 5 Quality Stars being the highest possible rating.

This is not to say that labs which failed the annual PT the first time are already doomed and will have to permanently defer COVID-19 testing. Such a move would be a disservice to the Filipino public who desperately need more access to COVID-19 testing. True to its objective of quality improvement, labs which failed the PT for the first time will go through process troubleshooting and root cause analysis to be submitted along with a detailed report to RITM. The Institute shall then provide a second PT panel to the laboratory upon receipt of the report.

Failing the PT again, however, would constitute the temporary suspension of testing activities while quality improvement actions are taken. The temporary deferment of testing activities however, shall not exceed 30 days after the labs receive the actionable technical recommendations.      

As RITM Laboratory Chief Amado Tandoc aptly put it, “It is important that we not only do this to get licenses renewed. We must participate in this program to ensure that all labs are striving and aiming for the level of quality that our families, friends and colleagues, and our fellow Filipinos deserve.”

Similar to NEQAS, QAP is here to stay for the long run

by Reina Manongsong, Communication and Engagement Office