ASCLS Today Volume 33, Number 3

Nadine Fydryszewski, PhD, MLS(ASCP)^CM, ASCLS Region II Director

The Merriam-Webster Dictionary defines people as “human beings making up a group or assembly or linked by a common interest,” and power as “the ability to act or produce an effect ... possession of control, authority, or influence over others.” People and power—two very strong words that when coupled can create a force that is unstoppable!

As medical laboratory professionals, we are a group of people with common interests. These interests include our individual and collective/group views. Power denotes the ability to act, to make change, to influence. As an individual, you have power to control your personal destiny as a medical laboratory professional. As a group, we have power to control our professional destiny as medical laboratory professionals. Our individual and group interests and power align.

“Remember, membership in and of itself is leadership and power. Even if you cannot commit to other leadership roles at various levels in ASCLS, you are a leader and you have power. Membership counts!”

One characteristic of a professional is joining your professional organization and actively being involved in that community of people who have like interests and the power to influence others and actuate change. What is the power? What are we empowered to do as professionals and as a professional community? Individually and as a community we have the power and responsibility for our actions and commitment to continue developing our professional expertise. We are the “voice, value, and vision” of the medical laboratory science profession.

As a community of professional people, our power is based at several levels. Membership is both individual power and community based, particularly related to power in numbers. A recent example is the Tennessee licensure issue in which timely response from members, the people, had a positive impact, the power. ASCLS Tennessee, working closely with a coalition of like-minded professional societies in the state and leaders of the licensing board, headed off legislation that would have gutted licensure in the state. Power to the people!

Membership numbers have meaning, too. Member involvement in the professional organization at any level can and will vary. Our work-life balance changes and we must adjust our time commitment. Remember, membership in and of itself is leadership and power. Even if you cannot commit to other leadership roles at various levels in ASCLS, you are a leader and you have power. Membership counts!

The People Power in ASCLS
The ASCLS organization structure provides “power to the people” at the state, region, and national levels. At all levels there is opportunity for individual and community voices to be heard at the ASCLS House of Delegates (HOD). This structure provides a forum for individual members to exercise their power in shaping the organization and profession. The power begins with each individual member.

The members who serve as state delegates at the national HOD represent each member in their state. They are their voice. The national, regional, and state leadership are responsible for assuring that the issues to be discussed and voted upon at the national HOD have been vetted at the state level and that each member has an opportunity to provide their input.

The venues can vary and may include the state HOD meeting, an open board of directors meeting, an online/teleconference meeting to reach a large group, or a survey to collect comments. The state delegates are charged with representing their constituent society members and presenting their collective views to national. At the national level, the ASCLS Board of Directors serves at the pleasure of the members. The “power to the people” at all levels.

We take pride in the work we do, and in our profession. Take pride in ASCLS and embrace the “Power to the People” as a force that is unstoppable!

Nadine Fydryszewski is professor and program director of the Doctorate in Clinical Laboratory Science (DCLS) and MS in Clinical Laboratory Science (MS-CLS) Programs at Rutgers University, School of Health Professions, Department of Clinical Laboratory Sciences, in Middletown, New Jersey.

IMPROVING PATIENT AUTONOMY OR RISKING PATIENT SAFETY?

Brandy D. Gunsolus, DCLS, MLS(ASCP)^CM, ASCLS Patient Safety Committee Member

In traditional healthcare, all patients visit their physicians, receive a laboratory order for tests, results are sent to their physicians, and the physician would then notify the patient of the results. Times have changed.

Now patients can go online, to the local pharmacy, or the mall and obtain virtually any laboratory test they want. The debate about direct-to-consumer (DTC) testing has been ongoing for several years and, whether we agree with it or not, it appears to be here to stay. Within the vast market of DTC testing is an exploding subset: DTC genetic testing. More than a dozen different companies now offer DTC genetic testing¹. This type of testing includes things as seemingly benign as genealogy and ancestry, but also includes family relationships and supposed markers of inherited disease.

Why Do Patients Obtain DTC Testing?
What entices patients to pursue DTC genetic testing? While research has been limited, one study looked into this question in the Ashkenazi Jewish community. The findings were somewhat unexpected: 64.3 percent stated they wanted to test for cancer; 42.0 percent to know their risk of cancer; 25.0 percent said it would benefit their family; 16.1 percent was to address their anxiety; 13.4 percent wanted to help advance research; and only 5.4 percent was for future family planning². This was unanticipated as this population is known to have prevalence for several devastating genetic diseases, yet the smallest percentage was for family planning. While this finding may not extrapolate to society as a whole, it does provide a glimpse into a strong desire to test for fear of disease, primarily cancer.

So why do patients not obtain this testing through their physician? No studies have reported on this aspect. It could be speculated that cost is a major issue. DTC genetic testing often costs hundreds or thousands of dollars less than traditional healthcare routes. There are also restrictions on what health insurance will cover, leaving patients bearing the financial burden. While insurance companies do not cover DTC genetic testing, there is now some limited insurance coverage for repeat testing of specific markers found positive in DTC testing (e.g. BRCA1/BRCA2)³.

Test Result Confusion
Do patients understand the implications of DTC genetic testing? Limited research has been done to answer this question and anecdotal reports are mixed. One survey comparing DTC genetic test result interpretation between patients and genetic counselors identified that patients were significantly more likely to misinterpret results than genetic counselors; however, the reports were still frequently misinterpreted by even the genetic counselors4. Result reports are generally provided as variant detected or not-detected and a risk analysis. The risk analysis has been cited by many, including the FDA, to be confusing and, in some cases, completely inaccurate⁵.

The confusing reports, as well as unsubstantiated healthcare claims by DTC genetic testing companies, has led the FDA to take action against several DTC companies5. With confusing test reports, patients are unlikely to understand the ramifications of their results that could lead to anxiety and pursuit of unnecessary additional testing and medical procedures. While DTC companies now list questions patients should consider prior to having genetic testing and given that this testing was one of the hottest holiday gifts recently, it is doubtful individuals heeded the information in the questions⁶.

The most troubling aspect of DTC genetic testing is the accuracy of results. There has been more than one report of individuals submitting their information to multiple companies only to receive conflicting results⁷. Another study recently identified that 40 percent of all DTC genetic test abnormal results were false-positives⁸. One news reporter submitted his dog’s sample and a company not only failed to identify that the sample was not human, it reported “her muscle force would probably be great for quick movements like boxing and basketball, … has the cardiac output for long endurance bike rides or runs. They did advise she might want to work with a personal trainer.”⁹

Families have been solidified and torn apart by DTC genetic testing. Anecdotal reports have individuals discovering one parent is not biological and adopted individuals identifying parents who did not want to be found. Parents are also choosing to have their newborns tested by DTC genetics¹⁰. It is unknown if their attitudes toward their infants change once they have identified genetic variants via these tests, that may not even be correct.

Privacy and Designer Baby Concerns
Broader concerns of DTC genetic testing exist as well. Over the last year both DTC companies 23andMe and Ancestry.com have sold patient data to other companies including pharmaceutical companies, biotechnology research companies, and even Google¹¹. This not only raises privacy concerns but questions the potential usage of the data. Until recently, it could be argued that these massive genetic databases could only be used for research in developing better diagnostics and treatments. But what else could be done with this data? Potential exists for insurance denial for carrying specific genotypes and employment discrimination if risk for future disease is thought too high.

Recently, a researcher in China identified a gene that allows the human immunodeficiency virus to infect cells, used CRISPR technology to remove the gene in human embryos, and implanted the embryos into a woman without following standard ethical protocols. The woman subsequently gave birth to twin girls¹². Could the information from these DTC genetic databases be utilized similarly to identify ways to create the designer babies of the future? Only time will tell.

While the debate on DTC genetic testing will continue, it appears it is here to stay. As laboratory professionals, we are the most knowledgeable in being able to decipher good tests from bad. Our patients are obtaining this testing, often without recognizing the implications, and then receiving results that nearly half of the time are shown to be incorrect. It is up to us as professionals to help educate others of the true implications of these DTC tests.

References:

1. U.S. National Library of Medicine. What is direct-to-consumer genetic testing? (updated 12/18/2018, accessed 12/27/2018).
2. Garg R. “Why do people undergo genetic testing – for personal benefits, for family, or for science and society?” Atlas Sci. Jan 2016.
3. Matloff E. “Building A Bridge From Direct-to-Consumer Genetic Tests To Reality.” Forbes. Sept 2018. (accessed 12/27/2018).
4. Leighton JW, Valverde K, Bernhardt BA. “The General Public’s Understanding and Perception of Direct-to-Consumer Genetic Test Results.” Public Health Genomics. 2012;15:11–21.
5. Matloff E. “How Accurate Is Direct-To-Consumer Genetic Testing? From Gold(ish) To Garbage.” Forbes. May 2018. (accessed 12/28/2018).
6. Molenti M. “Ancestry’s genetic testing kits are heading for your stocking this year.” Wired. Dec 2017. (accessed 12/28/2018).
7. Cussins J. “Direct-to-consumer genetic tests should come with a health warning.” The Pharmaceutical Journal. Jan 2015;294(7845). doi: 10.1211/PJ.2015.20067564
8. Tandy-Connor S, Guiltinan J, Krempley K et al. “False-positive results released by direct-to-consumer genetic tests highlight the importance of clinical confirmation testing for appropriate patient care.” Genetics in Medicine. Mar 2018;20:1515-1521.
9. Rogers P, Capitanini L, Copenhagen C. “Home DNA Kits: What Do They Tell You?” [news report] (updated 05/04/2018, accessed 12/28/2018).
10. Wyckoff AS. “Lack of reliability, privacy plague DTC genetic tests for newborns.” Amer Acad Ped. Oct 2018. (accessed 12/28/2018).
11. Brodwin E. “DNA-testing companies like 23andMe sell your genetic data to drug makers and other Silicon Valley startups.” Business Insider. Aug 2018. (accessed 12/28/2018).
12. Molenti M. “US biotech firms made China’s gene-edited babies possible.” Wired. Nov 2018. (accessed 12/18/2018).

Brandy Gunsolus is Doctor of Clinical Laboratory Science at Augusta University Medical Center in Augusta, Georgia.

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Julie Bayer-Vile, MS, MLS(ASCP)^CMSC^CMMB^CM

Delegates to the ASCLS House of Delegates (HOD) discuss Society business and governance that is voted on by the HOD during the 2018 Annual Meeting in Chicago.

Having been a member of ASCLS for almost five years now, I’ve had the privilege of attending and serving as a delegate for my state society at two ASCLS Annual Meetings. Ensuring that the voices of all our members and constituent societies are heard is a priority to the ASCLS Board of Directors and is a key element to the continued forward progress of the Society. In the face of adversity and a changing demographic of our members, and our field in general, it is more important than ever that ASCLS finds a way to stay relevant and adapt to meet the needs of our members. The next step in our organizational evolution should be a restructuring of our Society voting process.

Time for a New Voting Process
As it exists now, our voting structure is such that only people who attend the Annual Meeting, and are credentialed as delegates through their state, can have their voices heard through voting in the House of Delegates (HOD). As tuition and student debt are increasing and salaries not keeping pace, younger members may have more difficulty attending our meetings. I for one have never had an employer who would give me educational PTO for even a state meeting, let alone any kind of PTO or financial support for a national meeting. By precluding the voices of members unable to attend, we are not representing the diversity of our membership in important business matters.

In 2018 only about 3 percent of our membership were credentialed delegates on the floor during the meeting. As a result, the direction of our Society is more driven toward the views of those who are in attendance. As a younger member, this is discouraging. My voice and my thoughts aren’t any less worthy because I’m not able to attend the meeting every year. Part of the ASCLS mission defines ASCLS as “an organization where all persons can engage and participate in a meaningful way.” If we, as an organization, are going to make this statement, then we need to stand behind it and make the changes needed so all of our members have the opportunity to be engaged.

Regional Director Elections
Along with changing the voting process, we also need to evaluate the way we elect regional directors. As a member of Region II, I should not be voting for the director of any other region. As a member of my region, I am familiar with the needs of my state and the needs of the states in my region. I am not, for example, familiar with the needs of Colorado or Florida. It’s not my place to vote on a director when I don’t know what the region’s states need in terms of regional leadership. Similarly, I don’t want someone from another state voting on my regional director.

The candidate who wants to be the director of my region should be campaigning to me and telling me what they’re going to do to better my state and my region. I don’t want them to be concerned with courting the votes from anyone else. Their focus and constituency should be entirely their region. I don’t feel that it’s in the best interest of any state or region to have the regional directors voted on by all delegates. Just as I don’t vote for a senator from another state, I shouldn’t be voting for a director for another region.

Eliminate the Delegate Structure
There are changes we can make to better represent our organization and our diversity. We should eliminate the delegate structure. All dues paying members have the right to be voting members in the Society and should be allowed the opportunity. We should also move to an anonymous online voting system with live stream of the HOD meeting, which should be renamed to reflect that it is a business meeting. Other professional healthcare organizations, including the American Association for Clinical Chemistry and the American Association of Physicists in Medicine, conduct their voting online.

This meeting still provides a great deal of value and discussion for voting. By live streaming the meeting, it allows for virtual attendance and interaction by those unable to make the meeting. Voting, on some matters, can still happen during the business meeting and can be conducted through an online balloting system. We use online voting for regional directors already, so the same can be put into place for business voting. Allowing all members this opportunity is empowering and I believe fosters a stronger feeling of ownership and investment in the Society.

Disrupt the Status Quo
For as strong a voice as ASCLS is for the clinical laboratory profession, we can do better. Some of our operating procedures are antiquated and do not foster engagement with younger members, and this is a prime example. I believe if we are going to continue to survive, and thrive, we need to adapt to the environment we’re in now, not the environment of 20 or 30 years ago.

Sometimes, disrupting the status quo is the best way to make progress. All members deserve to have their voices heard. By making the Society, and our decision making, more transparent and accessible, we’re going to empower our members to be more involved and more invested in the future of the Society. Improving accessibility includes meeting our members where they are in their lives, personally and professionally. But, as the structure stands now, I feel that voting is a privilege for those able to afford to attend a meeting, not a right afforded to all dues paying members. I pay the same dues as every member in the Society. Whether I can attend a meeting or not, for whatever reason, should not limit the weight of my voice. We should all have the right, and opportunity, to have our voices heard.

Julie Bayer-Vile is the cancer conference coordinator at CJW Medical Center in Richmond, Virginia, and an incoming master’s in genetic counseling student at Virginia Commonwealth University.

Cheyenne Reyes, ASCLS Region VII Developing Professional Representative

Photo credit: CDC/ Jim Gathany

While completing her degree in medical laboratory science, Cheyenne Reyes worked as a phlebotomist. This gave her a unique perspective of the laboratory through the eyes of phlebotomists.

As most of us have experienced before, very few people know what we do as medical laboratory scientists (MLSs). However, most people are aware of the nursing profession, and many know of phlebotomists. The reason is simple: patients see and communicate with them.

Phlebotomists are the foundation of the laboratory, and as I have heard at many clinical sites, “our results are only as good as the samples that are given to us.” The symbiosis of phlebotomists and laboratory scientists is of substantial importance. In some places, the MLS collects their own specimens, but most of the time laboratory professionals depend on phlebotomists or nurses for collection. Phlebotomists are our connection to patients. What would medicine be without laboratory results and people who are intimately familiar with them? On the other hand, what would the laboratory be without specimens on which to perform these tests?

We are all aware of the issues that arise when laboratory results are misinterpreted or mistaken in some way. Knowing these difficulties, try to imagine a world in which there are no laboratory results of any sort to aid doctors in their diagnoses. Laboratory science plays an important role in medical advancement. Without it, medicine would not exist as we know it. However, each test must be performed on a patient’s specimen, most commonly his or her blood. If it weren’t for phlebotomists, the laboratory scientists would have to draw their own samples, leading to a delay in patient results. Often, patient data is the sole reason for a diagnosis, and they are very time sensitive. A span of 30 minutes can mean a world of difference for a stroke patient. We depend on our phlebotomists to collect quality samples that are transported to the lab quickly so we can perform tests as soon as possible.

My Experience as a Phlebotomist
As an MLS student, I was given a wonderful opportunity to be trained on the job and work as a phlebotomist while taking classes. Thanks to this job, I have gained an understanding of the laboratory that many of my peers have not experienced. During my time at work and in clinicals, I noticed some laboratory scientists pay little attention to what phlebotomists must deal with, which inspired me to pass out a survey to both phlebotomists and medical laboratory scientists.

In my survey, several phlebotomists did not feel respected or appreciated by their laboratory scientists. Phlebotomists have expressed that MLSs “look at our title as nothing,” even though “we are a major part of the lab.” Some even feel as though they are viewed as working for the laboratory professionals, rather than with them.

While I am fully aware that samples must be held to a certain standard, we also must think about how many times that patient was probably stuck to get that 1mL of blood. The phlebotomists must go up to that patient and tell them they must try to draw blood again for the 16th time in an hour because the last sample was not good enough. If we need a recollect and their outpatient waiting room is full, we must have patience or be willing to help. Receiving samples from the pneumatic tube system, drawing outpatients, and answering the phone may not seem like a lot, until you are in the middle of it. They do not need a laboratory professional to ask them about another sample that needs to be recollected every five minutes.

During my few years of work and school, I have met a variety of people working as medical laboratory scientists. They have bestowed upon me knowledge that can only come from many years of experience in the field. While some may be surprised to learn about the lack of respect toward phlebotomists, the results of this survey seem to indicate that the feelings of the phlebotomists are not unfounded. Many medical laboratory scientists firmly believe in aiding and thanking their phlebotomists. However, there are a few that believe phlebotomists “shouldn’t feel anything” about their unwillingness to help because it’s the phlebotomist’s job, and “they will feel thankful if I’m willing to help.”

Working Together with Mutual Respect
The attitude that is expressed in statements like these are not conducive to a productive environment. A key factor in the laboratory setting is building trust among all employees, no matter their title. We all want to feel appreciated, and we should apply that to our phlebotomists as well. They represent our laboratory to the patients we do not see. If they are miserable at work, consider the impression it gives the patients about the lab.

The laboratory is one big instrument. All departments play their own role, and for everything to run smoothly, all the pieces and mechanisms need to be working together. While most laboratory professionals are aware of this, phlebotomy is often overlooked. Unfortunately, this is not an uncommon occurrence. If we encourage growth, support, and trust within our lab, including the phlebotomists, we grease the wheels to a dependable and efficient machine.

Cheyenne Reyes recently graduated with a degree in medical laboratory science from the University of Louisiana Monroe.