Why can’t we hasten accreditation for laboratories testing for Covid-19? Misplaced priorities and long rolls of red tape.

By Reuben Pio Martinez

Just recently, the Department of Health (DOH) finally gave the go signal for UPLB’s COVID-19 Molecular Diagnostic Laboratory (UPLB-CMDL) to operate. This came about after more than two months of preparation by the Task Force LB Kontra COVID-19, alongside their own committees and partners (READ: https://bit.ly/COVID-19TestAGo).

While the knowledge of the facility can test Laguna residents for the disease, starting July 6, 2020, the lengthy accreditation period from DOH left many baffled, as the long days prevent vulnerable citizens from being tested by experts. A similar case can be observed with several other potential testing centers, all across the nation.

Though the likes of Presidential Spokesperson Harry Roque cheered at the mere thought of supposedly beating the UP predictions by a very small margin, one fact remained: the numbers told different stories.

If we compare the statistics that we have here to our neighboring Asian countries, we are indeed one of the most struggling, and have the lengthiest lockdown.

If one were to do the math, how does DOH being “slow and steady” cost us the race for our very own lives?

How to be accredited

Out of the five Task Force committees, two took charge of overseeing the retrofitting of one of the National Institute of Molecular Biology and Biotechnology’s (BIOTECH) Immunology Laboratory. 

The first is the Committee on Establishment of the UPLB COVID-19 Testing Center. Headed by UHS director Dr. Jessie Imelda Foronda-Walde, this committee worked to ensure that the facility would function according to DOH’s and the World Health Organization’s (WHO) structural standards.

The second is the Protocol Establishment Committee. With BIOTECH research assistant professor Dr. Severina Exconde heading the committee, members worked in crafting the guidelines necessary to manage the facility. These guidelines would be based on the approval of the Research Institute for Tropical Medicine (RITM).

Both worked hand-in-hand to have the facility be recognized as a certified COVID-19 testing facility. Among such measures taken to achieve this include the training of potential staff members in detecting Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2). This took place last June 26, where six medical technologists garnered perfect test scores for their performances.

To understand the process itself, one would have to take note of the different stages. According to DOH’s regulations, there are a total of five steps that concerned parties have to take in order for a testing laboratory to be accredited.

The first stage, Self-Assessment, RITM would be providing tools for constituents to evaluate their own project. These tools would help assess the access to and design of the laboratory, the usage of safety equipment, the administration’s management, documentation and training.

The second stage, Validation, would see a team composed of members from DOH, WHO, and RITM to evaluate the results of the self-assessments on-site. The inaccuracies would be rectified by the visiting team, and the laboratory staff would have to make the necessary adjustments based on the recommendations.

The third, Personnel Training, would have the facility’s staff undergo a three-day training at the RITM laboratory.  Then, Proficiency Testing, managing staff members would already be given the chance to obtain samples, but would have to test COVID-19 positive samples from RITM before proceeding to the final stage, which is the Full Scale Implementation. 

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18

average days for accrediting a GeneXpert testing laboratory

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Time runs out

In analyzing and comparing the accreditation periods between various laboratories, Cure COVID CALABARZON’s Director for Policy Research Paul Carson observed that accreditation is much faster for those established within the National Capital Region (NCR).

For his study, Carson compared how both real-time reverse transcription-polymerase chain reaction (rRT-PCR)-based testing and GeneXpert facilities compared to one another.

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The gold standard of testing 

RT-PCR swab tests screen for the presence of SARS-CoV-2, the virus causing Covid-19, at the swab site — a positive result indicates an active infection. 

The former, considered as the supposed gold standard for COVID-19 testing, involves a process of replicating and comparing DNA strands, obtained from nose and throat swabs, in order to detect traces of the virus, and would yield results around 24 hours or more. The latter also involved a similar process, but are said to deliver results within an hour or less.

Statistically, GeneXpert laboratories were accredited in an average of 18.37 days. This in contrast to how ones based outside of Metro Manila had to undergo 17.65 days, and those within it have about 19.6 days. A factor for this is that NCR-based GeneXpert facilities were accredited earlier than normal, unlike those outside the region.

The duration between stages also varies among regions and laboratory types. According to Carson, Stage III to V accreditation lasts for 15.38 days in NCR, and 25.61 days outside it, although the overall average for rRT-PCR-based testing laboratories is 22.63 days. Meanwhile, Stage V accreditation in Metro Manila lasts for about 12 days, while on the outside, about  18.06 days.

Carson added that Stage III to V accreditation lasts for extreme periods, with about 12 laboratories already for 48 days, almost obscuring any chance for them to reach the final stage. 

“Ultimately, these questions need to be asked, specifically, for public discourse and transparency. Similar to how we do not know the actual spread of the virus yet, we also need to know the specific action to track, trace, and isolate the virus.”

Paul Carson
Cure COVID CALABARZON’s Director for Policy Research

Roots of the problem

Joshua Miguel Danac, Convenor of the Scientists Unite Against COVID-19 (SUAC), explained in an interview some of the factors affecting the process.

Among which is the technical capacity of staff members to perform testing during the crisis. Danac commented that due to the limited training given to medical technicians to facilitate the necessary tasks, most staff would be required to redo the examinations again so as to ensure optimal operation.

Danac also elaborated on how the insufficient access to the necessary technical equipment stalled the process, noting how most of the needed items are costly. Such instruments are needed for a laboratory to be noted as in compliance with DOH and RITM’s requirements.

This was a luxury that Danac noted to have been prevalent in facilities within NCR.

However, Danac explained that, besides DOH and RITM being burdened with numerous responsibilities, there are factors such as political pressure that hastened the entire process

In one notable instance of a laboratory being accredited following a lengthy process, Marikina City Mayor Marcelino “Marcy” Teodoro and his constituents defied DOH’s orders to halt the city testing facility from operating, starting on April 17. DOH then attempted to halt the operation due to the staff of the laboratory, which was said to be around 80%-90% completion, needed to undergo biosafety training.

Teodoro, evoked his authority to make independent decisions in a city’s wellbeing, explained that though the city government cooperated with the necessary measures, the process was simply too tedious for them. This was especially with the rising number of confirmed cases within Marikina at the time. 

On why GeneXpert laboratories are able to be accredited faster than rRT-PCR-based testing facilities, Danac explained that there are already such facilities in the country. This is even with the limited number of GeneXpert units available, with some of them said to have been used for tuberculosis treatments. Danac said that repurposing GeneXpert laboratories from tuberculosis treatment to COVID-19 handling is much simpler than building from scratch.

Plagued by the numbers

SUAC19 explained that the increasingly sluggish accreditation process and the current lack of accredited testing sites brought about a delay in presenting essential numbers in cases. This in turn led to a skyrocket in two types of data backlogs.

The first being Laboratory Backlogs, which describes swab results that are not released within a day or two, despite rRT-PCR tests having a turnaround within those two days This is caused by a lack of experienced personnel to handle the necessary equipment, and the general insufficiency of the aforementioned equipment and consumables, such as laboratory supplies.

The second being Validation Backlogs, which describe results that have not yet been checked by DOH for potential duplicates or errors, leading to said data not being included in the agency’s daily tally. This was said to be caused by a lengthy manual tallying procedure and lack of manpower to perform the tasks.

To understand the issues regarding this, the Coalition for People’s Right to Health presented an infographic online, which explained that from laboratory backlogs, there would then be validation backlogs.

Following this would be delays in contact tracing, wherein physicians would pinpoint people in close contact with the infected person, then with mass testing.

SUAC19 explained that as of June 1, there are now 2,231 laboratory backlogs, and according to DOH undersecretary Dr. Maria Rosario Vergeirie, 6,800 validation backlogs and more.

In an informal analysis written by Danac and Martin Carlo Belen, it was revealed that there were 222 cases when the result was released before the laboratory confirmed receiving the specimens, and 752 being confirmed despite the results not yet being released.

Laboratory test results are only released within three to four days, while another three to four days for case validation. From diagnosing the patient, to gathering specimens, to releasing the results, to validating, the average number of days overall lies around 11 to 13 days.

A quick boost

Concluding that there is an “indicative sluggishness” in accrediting both rRT-PCR and GeneXpert facilities, Carson questioned the factors that affect the overall procedures, which is needed to be discussed with the public.

“Ultimately, these questions need to be asked, specifically, for public discourse and transparency. Similar to how we do not know the actual spread of the virus yet, we also need to know the specific action to track, trace, and isolate the virus,” Carson wrote, while noting the large costs needed to procure the equipment and the establishment of facilities.

“Both private and public hospitals must do everything they can to stop being businesses.”

Danac and two other members of SUAC19: Maria Carmela Maranan and Stephanie L. Tan, recommended four solutions to increase the COVID-19 testing facilities’ capability to commit to testing.

These include providing a faster accreditation by aiding the laboratories in preparing, having public and private laboratories distribute samples, centralizing the procurement of the essential equipment, and allocating more personnel to handle the tasks.

Danac commented how due to the increasing expenses in procuring the equipment and the facilities, the government and all other private institutions must waive the payments and focus on helping the people. He said that both private and public hospitals must do everything they can to stop being “businesses.”

The real enemy?

These findings make it clear that the government has misplaced priorities, even in a time of an international crisis such as a pandemic. Whether or not the government would commit to any effort to remove bureaucracy to hasten testing would remain a mystery, and with days becoming increasingly bleak, perhaps any hope for mass-testing would last beyond the next few months. [P]