ASCLS Today Volume 33, Number 4

Joshua X. Pulido, MHA, MT(ASCP)

Respiratory tract infections are common and can be asymptomatic or manifest as a mild illness with progression into serious complications, hospitalization,^1,2 or death.⁴ Influenza and other viral pathogens such as adenovirus, human metapneumovirus, respiratory syncytial virus, and rhinovirus are common causes of respiratory infections.³ Early identification and diagnosis of these pathogens may allow for initiation of treatment⁵ and serve as a confirmation of an outbreak to control or mitigate the spread of influenza.⁶

Diagnosis of these common infections utilize the clinical presentation and diagnostic assays. This may present a challenge as overlapping symptoms make clinical presentation for respiratory infections inadequate for diagnosis.^7,8 Laboratory diagnostics of respiratory infections have made immense strides over the last several years to provide timely and actionable results during a patient encounter.

“With the clinical diagnostic landscape changing and migrating to molecular testing methods, the quality of the patient result is just as important, if not more important, than the accelerated turnaround time.”

Laboratory Diagnostics
Laboratory diagnostic testing for respiratory assays has been evolving over the last several years. The clinical laboratory has a wide range of techniques and assays from traditional microbiological respiratory cultures, direct fluorescent antigen (DFA) testing, rapid serological assays, and pathogen-specific molecular assays. Each serve a unique purpose and have a place to coexist in the laboratory.

Conventional testing methods are subjective and can depend on user technique and experience. Another limitation of these methods to consider is turnaround time. Many of these conventional methods may take several hours to days or weeks to complete. On the other end of the spectrum are rapid serology-based assays. These rapid assays allow for a quick screen to see if a particular pathogen is present and positives are usually then confirmed by other laboratory methods.

Molecular testing is emerging as the method of choice for clinicians for respiratory viral infections. Early molecular assays were designed targeting a single pathogen but over time have evolved into multiplexed panels allowing labs to test a single specimen for multiple pathogens. An advantage that molecular testing provides is a rapid turnaround time. Most respiratory pathogen molecular test results are available within a couple of hours with some taking less than an hour. While results are available much quicker, there is an added cost for the convenience. This may be accounted for in the cost of the assay reagents and/or in reimbursement for the testing based on clinical presentation and diagnosis.

Impact of Quality on Patient Results
There are many considerations in which a diagnostic laboratory test is right for an individual lab; it is important to remember there is a patient on the receiving end of the result. While one option may be attractive and cost efficient, is it providing the best result for your patient population?

There has been a change in the practice of quality control in a clinical laboratory recently. Labs are usually comfortable with QC in core areas, such as chemistry and hematology, and microbiology, but molecular is not as well defined. In 2014, the Centers for Medicaid & Medicare Services (CMS) updated its policy to replace Equivalent Quality Control (EQC) with an Individualized Quality Control Plan (IQCP). This change took effect at the start of 2016 and required laboratories to perform routine quality control in accordance with Clinical Laboratory Improvement Amendments (CLIA) or establish their own risk-based ICQP plan demonstrating QC performance intervals up to 30 days if manufacturer’s instructions for use allow it.

Taking this into account, the amount of validation a laboratory must perform to validate an IQCP plan, to save a little up front on quality control costs, is it costing your laboratory more in the long run? Currently, many of us are seeing declining reimbursement and tightening budgets, which may make IQCP seem very attractive to save some cash flow on QC costs, but at what risk? Is your lab willing to accept the risk that a bad patient result creeps out of your laboratory due to less frequent quality control? What is the potential patient impact of a bad respiratory result? This could be minor, or it could be life threatening in a pediatric patient. Or consider the scenario in which the patient may have been treated improperly with an antibiotic instead of an antiviral and now they have developed a subsequent C. diff infection? How would this affect the credibility and reputation of your laboratory? 

As IQCP allows for intervals to be validated and risk to be taken, this means that a QC interval may span several days to weeks. Knowing that, is there the possibility that a group of bad test results were released and on the next QC event it was discovered, which would potentially cause several patients to be recalled for repeat testing? Will this become a public relations nightmare and result in lost outreach laboratory testing? Finally, what is the cost of pending litigation against your facility or laboratory for a bad laboratory result going out? Was the result the cause of mistreatment and/or occurrence of a sentinel event leading to litigation? How will this impact future business?

What This Means for You
With the clinical diagnostic landscape changing and migrating to molecular testing methods, the quality of the patient result is just as important, if not more important, than the accelerated turnaround time. Information is more readily accessible to clinicians in a matter of minutes to hours and it is of the upmost importance that the results we are generating are accurate and right the first time. We all play a critical role in advocation for quality in our laboratories, and the choices we make may not seem completely cost-effective upfront but may mean the difference between life and death for a patient and additional burdensome costs in reputation and litigation for the lab.

References

1. Mistry, R. D., Fischer, J. B., Prasad, P. A., Coffin, S. E. & Alpern, E. R. Severe Complications in Influenza-like Illnesses. Pediatrics 134, e684–e690 (2014).
2. Cate, T. R. Impact of influenza and other community-acquired viruses. Semin. Respir. Infect. 13, 17–23 (1998).
3. Hayden, F. G. Respiratory viral threats. Curr. Opin. Infect. Dis. 19, 169–178 (2006).
4. Ferkol, T. & Schraufnagel, D. The global burden of respiratory disease. Ann. Am. Thorac. Soc. 11, 404–406 (2014).
5. Sintchenko, V., Gilbert, G. L., Coiera, E. & Dwyer, D. Treat or test first? Decision analysis of empirical antiviral treatment of influenza virus infection versus treatment based on rapid test results. J. Clin. Virol. 25, 15–21 (2002).
6. Gaillat, J., Dennetière, G., Raffin-Bru, E., Valette, M. & Blanc, M. C. Summer influenza outbreak in a home for the elderly: application of preventive measures. J. Hosp. Infect. 70, 272–277 (2008).
7. Jiang, L. et al. Performance of case definitions for influenza surveillance. Eurosurveillance 20, 21145 (2015).
8. Campe, H., Heinzinger, S., Hartberger, C. & Sing, A. Clinical symptoms cannot predict influenza infection during the 2013 influenza season in Bavaria, Germany. Epidemiol. Infect. 144, 1045–1051 (2016).

Joshua X. Pulido is business development manager for Virapur/Microbiologics in St. Paul, Minnesota.

For more on Molecular Diagnostics, join the Molecular Diagnostics Scientific Assembly.

Allicia Gunderman

Before attending the 2019 Legislative Symposium, I was aware of the shortage of medical laboratory scientists. But seeing the magnitude of the shortage and oncoming retirement presented at the symposium was eye opening. The statistics presented there made me wonder why MLS professionals have so little visibility in a time of such dire need.

While I don’t know the definite answer to this, I do know that the majority of my classmates and I were not aware of the MLS profession until after finishing undergraduate studies in biology or similar fields that usually require graduate-level education to find a job in the field. When discussing this with my professor, who also attended the symposium, she mentioned that the biology program at the University of Minnesota did not want to advertise the MLS degree due to losing students from their program when the MLS is a much more technical and job-focused degree. This made me wonder what other barriers exist in making medical lab science more visible.

In terms of barriers to getting more workers into the MLS field, our profession could be overshadowed by other health career programs such as nursing, medicine, and pharmacy. Another cause of the workforce shortage could be increasing demand and wage stagnation in our program, which makes qualified students choose other fields. A lot of other health professions overlook the importance of the lab, so I wonder how laboratory professionals can emphasize how much healthcare depends on us without going to the extreme of walking out and seeing how our workplaces would run without us. That would ultimately harm patient care, which goes against our core beliefs.

“I believe that all of us are responsible for making our profession more visible, given how much of a shortage we face with high retirement rates and not enough new qualified graduates to fill those vacancies.”

Therefore, I feel that increasing our visibility as a profession, as discussed at the Legislative Symposium, is of utmost importance. We need to provide opportunities to students in community colleges, technical schools, and universities who are interested in healthcare, and educate them about the versatility of our profession. Another option would be to advertise at career fairs for professionals looking for a career change or those who have been chronically unemployed or underemployed in their current fields.

Social media could also widen our visibility in the current era of technology. I believe that all of us are responsible for making our profession more visible, given how much of a shortage we face with high retirement rates and not enough new qualified graduates to fill those vacancies. We could start by making scripted responses about the versatility and importance of our profession for people not used to promoting it. The more visible we make ourselves, the more people will see us.

In summary, the 2019 Legislative Symposium taught me about the importance of advocacy and visibility in medical lab science. We are in nearly every hospital or clinic, yet much of the staff is not aware of us and the importance of what we do. By extension, politicians are likely overall unaware of our work too, which is why going to Capitol Hill and speaking about the issues our profession faces is a necessity for us and the patients we care for. We strive for optimal patient care, just as nurses and doctors do, but as medical lab scientists we have more work to make ourselves visible and communicate the importance of our work with other hospital staff and within legislatures. As a student—and eventually as an employee/professional—I will continue working with ASCLS to promote medical lab science. I definitely hope to attend the Legislative Symposium next year and for years to come.

Allicia Gunderman is getting a Master of Medical Laboratory Science at the University of Minnesota Twin Cites in Minneapolis.

Cheyenne Reyes, MLS(ASCP)^CM

From left: Jessica Lawless and Cheyenne Reyes visited the staff of John Kennedy, senator from Louisiana, during the 2019 Legislative Symposium.

My first Legislative Symposium was an experience that I will forever remember. Being able to see how the government works and how it can so closely affect us in this profession was eye opening. We do not realize just how important it is for laboratory professionals to make themselves known to our governing bodies, but the truth is, our legislators have more control in their hands than we like to admit. Talking to our representatives and senators may not always feel successful, but they will remember our stories and struggles. If we continue to push and make ourselves known, there is bound to be someone who cares enough to make a difference and stand up for us.

I really appreciated the set up of the symposium. As someone who has no history or knowledge of the government and how it runs, the meeting we have before we go up to The Hill really helps. I was feeling overwhelmed and nervous because I was not sure about how anything worked in Washington, D.C. Having people who were very knowledgeable walk us through how certain legislation affects us and the best way to convince our congresspeople that these issues are important gave me the tools I needed to confidently speak out about the issues medical laboratory scientists face every day.

Going up on the Hill was exhilarating. Standing with 117 MLSs from 38 states to discuss the laboratory workforce shortage, PAMA, and laboratory-developed tests inspired me to become more active in politics. I learned just how much government affects our lives, even though many of us—including me—do not like to acknowledge politics. It is important for us to stay active enough to make educated decisions about who we choose to represent us. This is essential not only as individuals who work in healthcare, but as citizens of the country.

The opportunity that was given to me by way of the Legislative Symposium to speak with staffers of our congresspeople is one that few have, especially as college students. I spoke alongside several people from my state during most meetings, but after midday, the more experienced members let us branch out on our own. We tested how effective our arguments were and had the chance to strengthen our rhetoric without always having the more knowledgeable members there to cover us. It was a “learn by doing” situation that I appreciated. That is the way many medical laboratory scientists learn. Being able to figure out our own way of speaking with staffers was invaluable.

Overall, the ASCLS Legislative Symposium was a life-changing and rewarding experience. There is so much to learn about how a simple conversation with the right people can steer the way we live our lives. I hope to attend many more Legislative Symposiums in my lifetime.

Cheyenne Reyes is a medical laboratory scientist at Ochsner LSU Health Monroe Medical Center in Monroe, Louisiana.

Justin Hanenberg, MLS(ASCP)^CM

From left: Justin Hanenberg and Amanda Fulton organized a social gathering for ASCLS-CA at Angel City Brewery during their Oktoberfest celebration. And Justin represented ASCLS-CA at the 2019 Legislative Symposium in Washington, D.C.

Major changes are coming to the California chapter of ASCLS. A “changing of the guard” might be the most appropriate phrase to describe the shuffling of roles and responsibilities. California recently bid farewell to two long-time contributing members, Josh Pulido and Ginger Weeden, who moved out of state. We wish them well and congratulations to Minnesota and Oregon who get to adopt some great laboratorians. As new leadership steps in to re-invigorate the society, members have a variety of opportunities to take on small volunteer roles that have real impact.

The leadership of ASCLS-CA is making some changes with how the society will communicate with members in 2019. The state society website is desperately in need of a makeover. Currently, the position of web master is vacant and yearning for a web-savvy member to champion the project. In the meantime, the leadership has decided to let the website go dormant and focus on social media platforms Facebook and Twitter to broadcast news and events. Important documents, meeting notes, and flyers will be housed in the ASCLS Connect Community until the official re-launch of ASCLS-CA.org in late summer/early fall. We ask all members to direct their questions, comments, and community posting to the ASCLS-CA Facebook page or state sub-group on Connect Community.

A recent poll was conducted through the state society’s Facebook group to gauge member interest for future events. Leadership may be buzzing with ideas, but we needed to know which ones were of the most interest. Turn out for responses were low, though still helpful in steering the committee’s efforts for upcoming events. The word “community” kept coming up in conversations—we want to take an approach that weaves community building into continuing education seminars, social outings, and student outreach activities (the three most voted categories).

The starter event for social gatherings was done by Amanda Fulton and Justin Hanenberg at Angel City Brewery during their Oktoberfest celebration. The day was filled with stories of our laboratory careers, ideas for the profession moving forward, and ways to combine a weekend social cocktail with continuing education. California is a big state and planning for any event usually means planning two events to reach both northern and southern California constituents. Members should be on the lookout for these kinds of hybrid education and social activities in upcoming months. Members can host events with ASCLS-CA, too! Weekend hikes, attending events together, or maybe looking for a team to do trivia night at a favorite night spot—we want to let our members know that volunteering can be about what they enjoy.

So, keep ASCLS-CA on your radar to be an up-and-coming state society! We hope to launch some exciting new initiatives that combine learning with entertainment. I don’t want to give too much away just yet. We encourage members to get involved early if they want to get in on the behind-the-scenes happenings and be a part of the momentum. It’s a prime opportunity to help shape the future of the CLS community in California.

Justin Hanenberg is field application specialist for Binding Site, Inc., in Sherman Oaks, California.