The COVID-19 pandemic crises the United States is experiencing has highlighted the importance of having trained and competent laboratory professionals. Providing accurate, reliable, and timely testing to aid in the diagnosis and treatment of disease is the primary goal of the medical laboratory. The ability to meet the laboratory’s goal hinges on the competency of the individuals performing patient testing.
The importance of having qualified personnel to perform laboratory testing is magnified during a disease pandemic where each positive or negative result has public as well as patient concerns. (The results are also monitored by local and national officials as well as the media.) Verifying the competency of qualified individuals performing patient testing is accomplished through conducting knowledge and skill assessments at defined frequencies.
Despite the urgency of the moment, laboratories must still follow the CLIA ’88 regulations allowing only trained and qualified individuals to perform patient testing. In addition, CLIA ’88 mandates that the competency of laboratory testing personnel conducting non-waived moderate and/or high complexity testing must be assessed semi-annually after the individual begins patient testing, and thereafter annually (CFR §493.1413.9 and 493.1451.9). (The terms semi-annual and six-month are used interchangeably.)
Some specific initiatives have been implemented in response to the pandemic. The FDA has issued several emergency use authorizations (EUA) for COVID-19 tests to help address the testing needs of the nation. (A EUA allows a company to bring a medical device to the market much faster.) The College of American Pathologist (CAP) has also clarified the training requirements for laboratory testing personnel. According to the CAP’s latest guidance, the same training records may be used at different hospitals if testing is standardized across a hospital system. However, competency of non-waived testing must be completed at each site testing is performed irrespective of whether testing is standardized or not.
CLIA regulations explicitly state that competency of an individual performing non-waived moderate or high complexity testing at a CLIA-approved laboratory must be assessed semi-annually in the first year the individual performs patient testing. Many laboratories have interpreted the regulation as requiring an employee to do six-month competencies in each discipline. That is an incorrect interpretation.
Regardless of the discipline, once an employee has been trained on a test system, CLIA only requires two six-month competencies after the individual has begun patient testing unobserved.
Many laboratory training programs include the employee performing patient testing under the supervision of a qualified trainer. The trainee may test patient samples during training, but the tasks are considered a part of the overall test system training program. Once a trainee has completed training on a test system, signed-off by the trainer, and begins performing patient testing on a test system, the laboratory should schedule the two competency assessment dates.
Simply stated, the clock for the timing of the two six-month competencies begins when the employee is trained on a test system and begins testing patient samples unobserved. (Often, this is the day when the employee has been placed on the laboratory’s work schedule even though they may still need training in other departments.)
Depending on the length of training and size of the laboratory, the first six-month competencies may include test systems from different disciplines. Almost without exception (especially in small to medium-sized hospital laboratories), the second six-month competencies should cover the majority of the tests in the laboratory the employee uses to perform patient testing. It is important to remember that all test systems the employee is using to perform patient testing must be assessed on the due date of each six-month competency.
It is not unreasonable to expect there may be delays in meeting the timing of competencies during a pandemic. However, there are no exceptions for training and competency frequency. With many cities having a large number of civilians and employees infected, it is highly likely laboratory staffing will be negatively affected. Laboratory managers and supervisors should be vigilant in documenting any problems or delays which may impact compliance with the regulations. Documents explaining the circumstances involved in any regulatory or accrediting failure will prove invaluable during and after an inspection.
The COVID-19 pandemic is challenging the nation’s healthcare system. It has placed a spotlight on the valuable role laboratories fill in delivering quality healthcare. Medical laboratories are only able to meet the challenges because dedicated qualified and highly-trained individuals staff them. Laboratory administrators, managers, and supervisors must remember that training and competency assessments are ongoing and required during the pandemic and after.
Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. He has a Masters of Healthcare Administration from Ashford University, a Doctorate of Psychology from The University of the Rockies, and is a Certified Quality Auditor (ASQ). He is a Laboratory Quality Coordinator for Sentara Healthcare. Sentara Laboratory Services provides services for 12 full-service hospitals, five ambulatory care centers, and a large number of medical group practices. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.
No, I’m not talking about Netflix or HRH Queen Elizabeth II, nor am I making references to tiaras, bars, beer brands, or imminently deliverable babies…I am, of course, talking about Coronavirus as it would certainly have caught most of our collective attention in the media by now.
I really enjoyed writing last month’s list of what I think are important things on the horizon for pathology and laboratory medicine this new year, but this month let’s take a more topical turn. So put your surgical masks on, wash your hands, quarantine the next 10 minutes of your time and get ready as I take a shot at the novel 2019 coronavirus outbreak!
***Let’s talk about you and me, Let’s talk about COVID-19…***
A long time ago, in a galaxy far, far away (aka: last year, about 20 minutes north of my apartment in Manhattan) I was in medical school, on rotations on the floors of a hospital in the Bronx. I experienced the surges of two flu-seasons and had a fantastic little mnemonic to remember the viruses that caused colds in most patients. Depending on age and immune system status, you had to think about the principal three viruses we see all the time—I remembered them as: “c-A-r,” note the capital “A.” Let me explain; the letters correspond to coronavirus, adenovirus, and rhinovirus. The are in a general order of when they appear during the months of the year (as coronavirus and rhinovirus kind of switch off in the spring, while adenovirus is around always thus is capital designation). There are a few hundred viruses which contribute to cold/flu-like symptoms in patients and, unless a patient is compromised in some way, we really worry most about one of them. Hint: it’s the one we give shots for annually, more on that in a minute.
As far as this coronavirus outbreak is concerned, this is a “novel” (i.e. new) variant (read: mutation) of a respiratory viral pathogen that is affecting a disproportionate number of patients in higher severity than expected. Its official entity name has now been filed by the World Health Organization (WHO) as COVID-19—corona virus disease of 2019. The actual virus is a relative of the infamous SARS virus from the early 2000s. That was SARS, this is SARS 2.0—literally. This virus is designated SARS-CoV-2. SARS stands for Severe Acute Respiratory Syndrome and is caused by strains of coronavirus found in the remnants of infected individuals’ coughs and sneezes—please wash your hands—and causes a spectrum of symptoms from mild to severe including pneumonia, respiratory disease, and even renal failure.
How Does this Even Happen?
Okay, who took a sabbatical to Wuhan, China, and ate a wild fruit-bat salad? No one, that’s not how this works. But, if you’re looking for quick grocery store recommendations at the present moment I’d probably tell you to check out ALDI or a farmer’s market a few spots higher on the list than the Huanan Seafood Wholesale Market in Wuhan which harbored a majority of outbreak case-cause tracings. The bottom line is that COVID-19 and the SARS-CoV-2 have appeared in the world the same way the previous similar outbreaks have—through zoonotic mutations which then spread to humans. This zoonotic transmission is so effective to presenting humans with super infectious entities because it sends us pathogenic material we would have never seen before and our “naïve” immune systems are caught off guard. Now don’t get all panicky; yes, I’ve seen Contagion, Outbreak, and read The Andromeda Strain—in fact, I absolutely love when epidemiological medicine has the media spotlight. It’s a very exciting way to showcase public health, medicine, and—our favorite—laboratory professional work!
Basically, this process of mutation and transmission is the modus operendi of a viral particle. You can’t quite kill them, they’re not quite alive by biological definitions, they’re just packaged proteins on autopilot. They’re kind of like natural robots that want to propagate their species by adapting over time—they’re The Borg or Cybermen, depending on your sci-fi preferences. But both offending automaton predators have a mutual enemy in public health—a doctor (get it? TARDIS pilot and/or Beverly Crusher both work wonders in a pinch…) Anyway, it’s never just physicians, but a whole hard-working team of health advocates that conduct surveillance, field research, epidemiologic studies, and first-hand treatment.
***Side note: if you’re bored, in a hurry, or just don’t like my articles—don’t fret! Go watch that Osmosis video on COVID-19 and you’ll be up to snuff on the current outbreak in no time. Or in 12ish minutes.***
***Hey, you made it this far. Great! Interested to know more about the COVID-19 virus from our very own American Journal of Clinical Pathology? Visit here to learn more about the story of how this pesky coronavirus mutated its way into headlines. Fresh off the AJCP presses this month!***
You Should Update Your Antivirus Software
No doubt in my mind you’ve probably seen plenty of coverage about SARS-CoV-2 in the media. I’d also be willing to bet a lot of it is either dilute, sensational, or possibly even misleading. Regardless, there are always going to be people that don’t “buy in” to the public health message. If you remember Contagion¸ Jude Law’s character pushes the efficacy of “forsythia,” a homeopathic herb supplement that supposedly mitigates the horrible disease spread from southeastern Asia from improper food handling—if I recall correctly, it was a paramyxovirus that time. In this SARS-CoV-2 epidemic we have no current effective treatments, so prevention is key.
In an effort to address this type of health misinformation the WHO and CDC are actively disseminating as much educational information and graphics as they can write. Trying to dispense advice for the public including proper mask wearing, education videos, and myth-busting (i.e. hand dryers do NOT kill the COVID-19 virus, UV lamps do NOT kill the virus, thermal readers are effective in screening populations for symptoms within limitations, alcohol and chlorine do NOT kill the virus, receiving packages from China is still safe, pets don’t harbor the virus at this time, other vaccines do not affect this virus, saline nose sprays do not affect this virus, garlic/oils/other supplements have no effect on this virus, and all age groups are affected)—good stuff there. The most trusted sources of information regarding epidemics should be the representatives of functional medicine and health outcomes, doing work every day to make people healthier. Often times, politics, misinformation, or complex situations make information delivery harder than you’d think and the risks are increasingly high.
A Crown of Thorns: Don’t Forget About the FLU!
Flu vaccine deniers: turn away now or be healed! —or at least exposed to another point of view rooted in evidence-only concepts in medicine and population health. Consider the following: as of this month, COVID-19 has infected 43,000 people and killed 1,000 (approximately 2-3%). Remember SARS? That infected 8,000 and killed 700 (approximately 10%). MERS? 2,500 infected, 860 deaths (approximately 34%). And what about Ebola? 29,000 infectious cases with 11,000 deaths (approximately 40%). That was sourced from the Osmosis video with data from the WHO. Pretty impressive right? Well, not if you look at this: according to the CDC, the 2019-2020 influenza burden statistics include 36,000,000 infectious cases, with 17,000,000 clinical visits, 440,000 hospitalizations, and 36,000 deaths. One might say “hey, Dr. Kanakis, slow down there you’re spitting out all these numbers and the facts won’t lie. Looks like influenza only killed 0.1% of cases.” And you know what, you’re right. 0.1% is lower than the other viral epidemics. But check this out, because of the sheer number of cases, that means more people died of influenza than COVID-19, SARS, MERS, and Ebola COMBINED and those happened in other years. That‘s just this year’s flu season alone. I’ve talked before about recognizing and detecting the common cold vs. influenza before, check it out if you’d like a refresher!
We have influenza every single year, and it kills so many more people than we realize. If you want to talk about a terrifying, global viral epidemic, we’ve already got one. And it’s closer than you think. So wash your hands, reduce exposures if you’re sick or immunocompromised, get proper rest, eat well, exercise, read my articles every month, but most importantly—and I cannot stress this enough—get your FLU SHOT!
Thank you so much, see you next time!
–Constantine E. Kanakis MD, MSc, MLS (ASCP)CM completed his BS at Loyola University Chicago and his MS at Rush University. He writes about experiences through medical school through the lens of a medical lab scientist with interests in hematopathology, molecular, bioethics, transfusion medicine, and graphic medicine. He is currently a 2020 AP/CP Residency Applicant and actively involved in public health and education, advocating for visibility and advancement of pathology and lab medicine. Follow him on Twitter @CEKanakisMD
Archived in the ever-rich and exotic mythologies of the Greeks is the story of Pandora’s Box. It was actually a “jar”—which is strangely close to a “test tube” in my opinion. Pandora was given a wedding gift, a beautiful jar, with instructions not to open it under any circumstances. Curiosity killed the cat, so to speak, and she finally couldn’t resist. When she opened it, all the evil contained in the jar escaped and spread over the earth. She tried to close it but too late—the contents had already escaped. Only one thing remained in the jar at the very bottom—the Spirit of Hope.
I’m not sure the World Health Organization would agree with me, but “Pandemic” is very close to “Pandora.” In a world where international travel is commonplace the spread of contagious disease is a major concern. Rats on ships carrying plague may be a thing of the past, but viral-loaded passengers on an international flight happen every hour of every day. Think of all the headlines in the past decade that have highlighted international health risk issues. It seems that Pandora has unleashed a few additional mutated “evils,” and I doubt we’re through with all her mischief.
As laboratory professionals, we are essential to solving the public health issues confronting our world today. Rapid diagnosis, evidence-based research, viral load monitoring, susceptibility and pharmacological validation, managing toxicity—familiar territory for us, and just think of how much relies on our expertise? We are called on daily to be the platform and framework for “pandemic control” measures. Sitting in our clean, efficient, well-lit, safe and busy laboratories throughout our country it’s easy to forget there are bacterial and viral war zones not far from our shores…all it takes is a small rat on a creaky ship (or a young child on a red-eye international flight) to initiate a modern day plague world-wide.
Next time you hear “pandemic”, remember Pandora. Wash your hands, put on a mask, and peer inside that jar of hers and shake out some Spirit of Hope. Sprinkle it liberally around our laboratories and colleagues, and let’s roll up our lab coat sleeves—we have a lot of work to do!
–Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.