CEO SUMMARY: As government officials and IVD firms divert the lion’s share of COVID-19 tests to a handful of billion-dollar labs, in thousands of hospitals across the nation COVID-19 patients languish days longer before discharge because their hospital lab must send COVID-19 tests to outside labs and wait up to seven days for results. Yet, those same hospital labs have unused COVID-19 test capacity, but no supplies to run needed tests.
NO GOVERNMENT RESPONSE TO THE COVID-19 PANDEMIC has been a bigger failure than the concious decision by federal and state officials (including FEMA) to not deliver a larger portion of scarce COVID-19 supplies and test kits to the clinical laboratories of hospitals and health systems, as well as the few remaining community lab companies.
Every lab manager, pathologist, and lab scientist understands a fundamental principle of lab testing: the closer to the patient that a medical laboratory test is performed, the shorter the time to answer.
Faster Start to Therapy
The faster an attending physician can get the result of a COVID-19 test, the quicker that physician can start appropriate therapy. A faster start to the right therapy contributes to better patient outcomes and less mortality from a SARS-CoV-2 infection.
Local testing closest to the patient also comes with a major advantage that lab managers and pathologists understand. Local pathologists running the local lab know the referring physicians and often know those patients for whom the lab has provided testing over multiple years. This is a benefit because, as the ‘doctor’s doctor’, the pathologist can often help diagnose complex cases and identify the best therapies.
This is as true for COVID-19 as it is for any other disease or health condition. Yet, from the inception of the COVID-19 pandemic, federal officials and their state counterparts have given preference to the nation’s largest laboratories when deciding how to allocate the scarce supplies and SARS-CoV-2 tests labs need to meet the soaring demand. This decision automatically shortchanged hospital and health system labs, many of which are recognized as centers of excellence in laboratory medicine and diagnostics.
This favoritism was visible as early as March 4, in the earliest weeks of the pandemic. National news gave major coverage to the event that day at the White House where Vice President Mike Pence met with executives from a handful of clinical laboratory companies and in vitro diagnostics manufacturers.
All six of the the labs represented at this event were members of the American Clinical Laboratory Association. Apparently not invited to participate in this press event about the plans to increase the number of COVID-19 test were representatives from such lab organizations as the National Independent Laboratory Association, College of American Pathologists, and American Society of Clinical Pathology.
Hospital Labs Not a Priority
The message could not have been clearer to all the clinical laboratory professionals working in the nation’s 5,000 hospitals and independent lab companies. The federal government’s priority would be to direct scarce supplies and COVID-19 tests to the nation’s billion-dollar lab companies in preference to hospital and health system labs and community labs.
How has that worked out for federal officials and those state officials who followed that premise of “we can increase lab testing capacity faster by feeding the billion-dollar lab companies and shorting local labs”?
Yes, the ramp up at such lab companies as Bio-Reference Laboratories, LabCorp, Quest Diagnostics, and Sonic Healthcare USA (all in attendance at the White House press conference on March 4) was rapid. The number of COVID-19 tests performed the first week of March was a few thousand. By early April, it was 50,000 per week and by early May it was close to 120,000 per week.
But what has it cost the American public and patients infected with COVID-19 after the federal government decided to divert a major proportion of supplies and COVID-19 tests to a handful of big labs? And at what extra cost to the healthcare system?
In its interviews with many hospital and health system lab administrators and pathologists, The Dark Report has documented these two facts:
- First, every hospital lab interviewed reported that it had existing instruments and technical staff that gave it the capacity to do significant numbers of COVID-19 tests daily. But the supply chain often limited their actual COVID-19 test numbers to just 20% to 50% of their lab’s capacity.
- Second, every hospital lab interviewed confirmed that the turnaround times for COVID-19 inpatient tests referred to outside labs were averaging three to eight days. That meant a COVID-19 inpatient was occupying a hospital bed for several days more than if the hospital’s lab could have performed the COVID-19 test in-house.
This situation continues to the present day. The Dark Report is canvassing hospital labs weekly about their supply chain situation and the specific problems that an inadequate supply of COVID-19 tests creates for these labs and and their parent hospitals and health systems.
Hospital Labs with Capacity
All labs surveyed report continuing shortages of necessary supplies and tests required for COVID-19 testing. They also point out that their labs have the equipment and staff to do large numbers of COVID-19 testing locally, with same-day and overnight turnaround. But because they cannot get enough supplies, they are referring many COVID-19 tests to outside labs and waiting days for results.
The inability to perform the COVID-19 test locally and report results within 24 hours or less has a major negative impact on patient care. Using the example of COVID-19 testing for nursing homes, one lab director told The Dark Report, “It doesn’t do those nursing homes any good to test all their residents for COVID-19 and then wait almost two weeks to get the results. That kind of delay means those nursing homes would have to test everybody all over again. That’s why some lab directors say that testing individuals with a PCR test that takes 10 days to two weeks for results causes more problems than it solves.” (See “In Michigan, Short Supplies Constrain COVID Test Capacity,” TDR, June 1, 2020.)
Similarly, it is not good medicine to require a hospital lab to send an inpatient’s COVID-19 specimen to an outside laboratory, then wait 48 hours to six days for results—particularly when that hospital lab has the analyzers in place and technical staff ready to do such tests.
It is accurate to say that the frustration level of lab administrators, pathologists, and lab scientists working in hospital labs and community labs is quite high. They recognize that both the IVD manufacturers and government officials are directing a very large proportion of scarce collection supplies, tests, reagents, and consumables to a select number of favored lab companies. They also see how much their labs could improve patient care—in their parent hospitals and their communities—if they could get enough supplies and test kits that would allow them to run their existing equipment to full capacity.
Politics has played a role in government decisions about how to allocate the limited supplies of collection swabs, viral transport media, COVID-19 test kits, and reagents. Government officials at all levels—federal, state, and local—face criticism and negative news coverage if it appears that they are not responding effectively to the COVID-19 pandemic.
Hospitals Silent on Supply
There is one more interesting aspect to this situation, where government actions to favor a handful of huge lab companies as a way to rapidly increase the daily number of COVID-19 tests performed has gone unchallenged. Because of the high value that a fast lab test result for a COVID-19 inpatient has to hospitals, why haven’t hospital associations and hospital CEOs been more vocal about why hospital labs should be getting at least enough supplies to allow them to fully utilize their existing capacity to perform COVID-19 tests?
Short-Sighted Actions Affect Patient Care
LAST WEEK, THE BIG NEWS IN HAWAII was that the supply of COVID-19 tests to one of its two biggest clinical labs had just been cut by 50%. This action would restrict the availability of timely COVID-19 tests results across the entire state.
On July 8, the Honolulu Civil Beat published a concise description of the situation, writing: A major Hawaii laboratory that has conducted a large portion of COVID-19 diagnostic tests in the islands has suffered a major blow to its testing supply chain, which could cause significant delays in test result turnaround times.
The surge in COVID-19 cases in other U.S. states has cut Diagnostic Laboratory Services (DLS) off from chemical reagents from its primary vendor, Roche Diagnostics.
The reagents are used for the laboratory’s fastest molecular-based testing machines, said Mark Wasielewski, president of DLS. Reagents are chemicals used to test patient swab samples.
Major mainland laboratories such as Quest Diagnostic Laboratories and LabCorp of America are competing for the same supplies, he said.
DLS’ capacity will shrink from 800 tests per day to 250 tests per day and the laboratory will only conduct high-priority testing locally for the immediate future, he said in an email.
At 198-bed Holyoke Medical Center in Holyoke, Mass, on June 29 WGBH reported that the hospital had been down to zero COVID-19 test kits two weeks earlier and that it was forced to cancel surgeries. WGBH quoted the lab director who described a two-day wait for outside test results, which was causing delays when a patient visiting the emergency department needed to be admitted.
Contact Robert Michel at email@example.com.