The trouble with (non) standardized tests

Much has been written about the challenges associated with a paucity of diagnostic testing for the presence of COVID-19. Without adequate testing, it is difficult to identify and isolate those with the disease in order to prevent its further spread in the population. And once again, supply chain disruptions are contributing to the problem.

That said, it is not all the supply chain’s fault.  At first, capacity had more to do with public policy, specifically limitations by the U.S. Food and Drug Administration (FDA) on who could develop the tests:  The Centers for Disease Control and Prevention (CDC) and diagnostic test makers, like Roche and Abbott, but not public health laboratories. After problems surfaced with the CDC test, and demand soared beyond the supply, the FDA gave the go ahead for labs certified by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) to develop their own tests. Despite an unprecedented acceleration in time to market for many tests, the worldwide reach of the virus created demand on a scale not experienced in recent memory, and that’s when the supply chain issues came to the forefront.

According to the Association of Molecular Pathology (AMP), more than 85 percent of the 118 U.S. labs responding to a survey in late April/early May said supply chain disruptions had delayed or decreased their ability to provide diagnostic testing. The supply shortages were far ranging. More than 90 percent said they were currently or had previously experienced shortages in testing swabs; 88 percent had similar issues with transport media, and 81 and 79 percent, respectively, had or are currently unable to get enough of the right reagents or testing kits.

The severity of shortages differed by lab type. Forty percent of academic medical center and community laboratories reported supply disruptions for testing kits, compared to just 13 percent of commercial labs. Once again, fingers pointed to public policy. Two-thirds of labs at hospitals, health systems and academic medical centers said they were told they could not purchase testing kits or reagents due to government restrictions and/or allocation, while less than one-third of commercial reference labs reported similar issues.

From scarcity to variation

Generally speaking, the hospital, community and academic medical center labs are much closer to patients and are also able to turn tests around quickly (most in less than 24 hours), compared to the commercial labs, with 43 percent that said results took longer than 24 hours and some longer than six days.

A larger portion of academic medical center laboratories (57 percent) and community hospital laboratories (45 percent) also reported demand was lower than their current capacity, while only 37 percent of the commercial labs had excess capacity.

The disparity in supply availability, timing of results, and capacity could have important implications as testing demand increases with the resumption of elective and non-urgent care and the reopening of businesses and schools. Given more supply availability issues, some hospitals are working with the commercial labs to get test results back within two days, which is time enough for them to know whether a patient is infection-free before starting a procedure. But if the time frame is longer, the hospital must utilize its own lab resources, which may have supply issues.

The relative lack of supplies has also led more of the non-commercial labs (57 percent) to run three or more testing methodologies, compared to just 20 percent of commercial labs. By diversifying testing methods, respondents say they can pivot based on which reagents or other method-dependent supplies they receive. Different methods often have different hardware, software, and protocols; some tests have to run on a specific platform, while others can be run on multiple platforms. Regardless, variation introduces greater complexity and the potential for errors.

Finally, the survey respondents reported problems with variation in how and to whom they report test results. Ninety percent of respondents said they are reporting results to state health departments, but 85 percent also said they have reporting requirements with the Federal Emergency Management Association, the CDC and/or local health departments. Forty-three percent said the multiple reporting requirements negatively impacted workflow given a lack of standardization in what information is required and how it should be reported. Hospitals have also reported similar challenges with how they are complying with reporting requirements for demand and utilization to both government agencies and their own executive teams.

In light of the survey results, AMP has outlined a number of recommendations for public policy makers and laboratory stakeholders. These include standardizing reporting formats so they are compatible with electronic health records and laboratory information systems and establishing a centralized reporting agency to eliminate duplicate reporting. The AMP also believes that more centralized visibility into supply availability, lab capacity, and demand could help public-private partnerships allocate and deliver supplies to where they can be best utilized to meet evolving healthcare and community needs.

Standardization and centralization are recurring themes in meeting the demands of COVID-19 and future pandemics.  Once again, the ability for everyone to speak the same language and to share data across a common platform are paramount in times when making decisions and taking action can mean the difference between life and death.