Another Lab Week?

Another Lab Week?

Diane Avenoso, MPH, MT(ASCP)SBB, CQA(ASQ)

Joint Commission Laboratory Field Surveyor

This is not another Lab Week. Mainstream media, scientific, and political publications are rife with recommendations for increased laboratory testing as the first step in recovery from the pandemic caused by SARS-CoV2. Could this be the first Lab Week that non-medical people know what a med tech or clinical laboratory scientist (CLS) does? For the past two decades, laboratory training programs have been closing all over the country. When I graduated from med tech school in 1993, I was told I would probably be replaced by an instrument or a high school student. I was also told in second grade our country would be totally metric by the time I graduated from high school…

Laboratories are under a lot of stress these days. Almost all labs operate on tight budgets with skeletal staff. Although laboratory testing contributes to approximately 70% of all diagnoses, clinical labs are mostly invisible to the world. When the need to test hundreds of thousands, even millions, of people to combat the novel coronavirus disease (Covid-19) was realized, it wasn’t a surprise that labs could not immediately rise to the occasion.

The true test of leadership is how one functions in a crisis

To begin, guidance from the U.S. Food and Drug Administration (FDA) pivoted from overly controlling testing and kit distribution in February 2020 to opening wide the regulatory barn doors. On February 4, 2020 the Secretary of HHS justified emergency use authorization (EUA) of in vitro diagnostics for detection and/or diagnosis of SARS-CoV2. At first, labs were allowed only to use a molecular-based assay developed by the Centers for Disease Control (CDC), but on February 12, 2020, the CDC announced there were problems with one of the primers in their assay. Access for patients to get testing was also tightly restricted in February.

Normally, high complexity labs may develop their own new tests (Lab Developed Test or LDT) which do not require FDA approval. LDT can be used internally by the lab and approved by the medical director on the Clinical Laboratory Improvement Amendments (CLIA) certificate. The emergency declaration prevented labs from troubleshooting and creating their own molecular-based assays, losing about a month when testing could have happened. This lost month, sabotaged the possibility for contact tracing and containment.

On February 29, 2020, the FDA relaxed restrictions and allowed assays other than the defective CDC test, but the EUA process was onerous and lengthy and mandated that labs submit validation data to FDA within 15 days for authorization. The regulations continued to loosen up in mid-March. In late March, FDA updated their FAQ allowing “point of care” (POC) tests to be considered “waived.” The media is full of false claims about home collection/tests, availability and approval of test kits, unproven treatments, and home remedies.

The pandemic is giving real-time lessons to the consequences of under-funding science, ignoring experts, and the damage of politicizing information. However, there is also unprecedented open source collaboration between scientists and organizations, which is one comforting prospect. There could be other silver linings: support for basic science and research; identification of weaknesses and vulnerabilities; and preparation for a truly pathogenic bug. Covid-19 is terrible, but it’s also a dress rehearsal.

Lies, damn lies, and statistics

Questions swirl around the serology test that nobody can answer. What constitutes immunity? How long do the antibodies last? What quantity of IgG is needed and do those antibodies cross react with other coronaviruses? What material should labs use for quality control and validation? What does “qualified” mean in terms of testing personnel or type of laboratory under EUA? When will surveys and inspections resume? Perennial recommendations stand: follow the manufacturer recommendations; show approval by the CLIA laboratory director for new processes and exceptions; document everything.

Labs need support, leadership, credibility, and direction. This Lab Week, they may get more than the obligatory sheet cake, box of donuts from the doctors’ office, or the tee shirt from administration, but there will never be “Year of the Clinical Laboratory Scientist.” To be fair, most CLS do not enter the field for glory, recognition, or memes -- but respect, fair pay, and a sense of agency would help. I think we all can agree that no test result is better than a wrong test result. Relaxing regulations to allow untrained operators and unvalidated test kits will not help us find a way to open up communities in a safe and logical manner.

It’s tempting to jump to grandiose ideas and solutions, but taking it one day a time is more manageable. By our actions, SARCoV-2 was able to cross species and spread in humans -- a seemingly perfect host -- another zoonotic spillover will probably happen again. Social distancing is working but not sustainable. Let’s learn from this pandemic to take care of one another and prepare more effectively -- or better yet -- prevent the next one. The Joint Commission promises we are on the same team with healthcare providers. We stand with laboratory professionals and understand these are extraordinary times. We will learn from each other and find the answers together.