ASCLS Today Volume 32 Number 4

ASCLSToday Masthead 680

Volume 32, Number 4

The Need for NGS Technology in Infectious Disease Diagnostics

Rachel L. Alexander, MS, MB(ASCP)CM, ASCLS Molecular Diagnostics Scientific Assembly Vice Chair, Technical Supervisor for MicroGenDX

As a 2011 master’s degree graduate of the Texas Tech Health Science Center Molecular Pathology program, I was bright-eyed and eager to begin my healthcare career. I felt enthusiastic about being a part of this new and specialized professional group. I was certain that personalized medicine by molecular methods would sweep the nation. However, 7 years have passed since my graduation and most healthcare systems still depend on culture methods for patient treatment.

Though there are superb laboratories that provide molecular diagnostics, most applications are in the genomics field or are performed by private companies. The use of Next-Generation Sequencing (NGS), specifically regarding infectious disease, is sparse and profoundly underutilized. I constantly find myself asking the question: Why isn’t NGS being considered for the majority of patient care? 

Laboratory testing by microbial culture remains the primary diagnostic tool for infectious disease detection. Traditional culture methods depend on providing the necessary conditions for pathogenic species to reproduce. The conditions include predetermined agar or broth media, proper temperature, and time for suspected species to grow. A laboratory professional then assesses the plate for microbe speciation by established bacteriology knowledge. 

Culture can detect aerobic bacterial species in a relatively short time (typically 12-48 hours) for a low cost. It is also useful in the ability to detect antibiotic susceptibility for pathogen eradication. Antibiotic susceptibility testing is, however, limited since susceptibility can vary among species, and even strains, within the infection. Culture methods have other disadvantages including qualitative verses quantitative microbe amount, time for difficult species growth, low throughput, and contamination. Additionally, anaerobic species are usually not investigated until subsequent testing is required. 

Next-Generation Sequencing (NGS) is a term that encompasses several modern sequencing technologies. The data is obtained by rapid sequencing of DNA base pairs from isolated DNA or RNA. The application for infectious disease testing uses isolated patient DNA to detect and quantify (aerobic and anaerobic) bacterial and fungal species. The microbial species are identified by matching their specific DNA base sequences to national databases. The databases include over twenty-five thousand known sequences with a 99.9% detection accuracy. 

A large advantage of NGS technology for infectious disease is the ability to concurrently identify multiple pathogens within a single sample. This capability to detect a polymicrobial infection is especially valuable for patients with complex or chronic infections. Additionally, NGS data can be used quantitatively to detect percentages of each organism present within the infection. 

Another great asset of NGS is the ability to identify bacterial resistance genes. Antibiotic resistance genes present in one or more species can be passed to other species through horizontal gene transfer. This bacterial capability is the reason susceptibility testing is less relevant for treatment options, in my opinion. For example, an antibiotic may be prescribed that will work on one susceptible species but fail to eliminate the infection if any other species or resistance genes are present. By using NGS technology, a “personalized and targeted” treatment plan becomes standard for each patient. 

Infectious disease studies have demonstrated that NGS technology outperforms culture methods. A recent study highlighted that out of 44 chronic UTI patients, 13 had positive culture results whereas all 44 were positive on NGS.1 A study of prosthetic joint infections had similar findings. This study found that out of 28 patients suspected to have infections, cultures were positive for only 17 patients; whereas NGS was positive for 25 of the same 28 patients. Additionally, NGS identified 9 more positive patients, from which cultures had already determined were negative, for prosthetic joint infection.2

A popular area of NGS study is found in chronic wound care due to the difficult nature of treatment. By detecting the specific amounts and species within the wound infection, the patient may be able to save the limb from amputation or continual debridement. An example is found in a study comparing culture to NGS for 168 chronic wounds. A total of 17 different bacterial species were cultured, of which 3 species were found in some samples. NGS identified 338 different bacteria with up to 33 species found in some samples. While some of these species were not pathogenic or in high percentage, the 20 most common pathogenic aerobic and anaerobic bacteria that were found lead to significantly improved patient outcomes.3 

The lack of NGS implementation in mainstream settings is partially due to cost. Although the startup costs of NGS equipment can be high, the average sample cost can be lowered over time. For example, an average 400 sample run on the Ion Torrent PGM machine cost is similar to running 2-3 routine cultures. The cost of testing for patients is being lowered also since CPT codes have been developed for molecular testing and are now accepted by many insurance carriers. 

I believe the principal reason for lack of implementation, however, is the absence of awareness by patients and healthcare professionals. Certainly, these groups cannot be expected to request testing methods of which they are unaware. They also cannot understand the benefits of molecular testing without the appropriate information. 
I hope NGS testing becomes more widespread as evidence of its advantages continues. It is our responsibility as laboratory professionals to provide the best possible data for patient care. We are the ones performing the valuable services needed for treatment decisions. I urge you to consider how molecular testing could improve your patients’ outcomes.

REFERENCES

  1. Michael, McDonald et al. “A Head-to-Head Comparative Phase II Study of Standard Urine Culture and Sensitivity Versus DNA Next-Generation Sequencing Testing for Urinary Tract Infections.” Reviews in Urology 19.4 (2017): 213–220. PMC. Web. 27 Feb. 2018.
  2. Tarabichi, Majd. et al. “Diagnosis of Periprosthetic Joint Infection: The Potential of Next-Generation Sequencing”. The Journal of Bone and Joint Surgery. 100(2) (2018):147-154. PMC. 27 Feb. 2018.
  3. Rhoads, Daniel D. et al. “Comparison of Culture and Molecular Identification of Bacteria in Chronic Wounds.” International Journal of Molecular Sciences 13.3 (2012): 2535–2550. PMC. 27 Feb. 2018.
  4. www.microgendx.com

 

A Common Case

Kyleigh Ellis, Region VII Student Representative

Case Study:

A young, recent college graduate walks into a lab setting to meet with a clinical laboratory supervisor seeking a job. He is sweating profusely and seems to be shaking. Stuttering, he admits to being extremely nervous.

Signs & Symptoms 

  • Sweaty palms
  • Nausea
  • Weak knees

Clnical Signs

  • Nerves - slightly elevated
  • High blood pressure

I have been a microbiology technician at a local regional medical center for a little more than three years now and have worked with numerous doctors, nurses, and pharmacists during this time. The medical center employs great doctors and nurses who are respectful and understand the laboratory profession and our importance in providing quality patient care. However, we all experience anger from a disgruntled doctors or nurses at some point in our careers. It can be frustrating when trying to provide the best patient care. What causes this anger and lack of understanding? What causes the blame game?

After reading this case study, you know our patient can be diagnosed with pre-job interview nerves. However, we can’t let little ole nerves keep us from getting a job for which we have trained for so long.

Whether you’re finishing college or finding places to complete clinical rotations, you will find yourself sitting in an office, answering questions about yourself and trying not to bolt. It’s not easy or fun, and that’s coming from a very talkative, extroverted person.

Nonetheless, I’m here to help by sharing my tips for preparing for an interview and answering and asking questions. I have the treatment, if you will, for those pre-job interview nerves.

First things first - first impressions. You’ve heard it enough to have it engraved in your brain but here it is again: people form their impressions of you just by the way you look. So the goal with that logic in mind is to be clean and confident.

  • Take a shower. Yes, college students can get away with looking pretty rough on a daily basis, but this is not the time to practice a hippy lifestyle.
  • Invest in a good interview outfit. Okay, I know. We’re broke. Try to look for sales. All you really need is a good business jacket, classic button up, and dress pants. Sale racks work fine for this and you might have a good pair of khakis in your closet that you didn’t spill lunch room spaghetti on in high school. This tip is worth it! You can wear the same outfit to every interview.

Now, you’re ready for the questions. It’s like a first date and it might even be less awkward.

  • Have your resume and application in hand. Ask mom or the annoyingly organized classmate next to you to borrow a manila folder. Sweaty, wrinkled pages be gone. Plus, you look that much more professional.
  • Rehearse like it’s a show on Broadway. I can’t stress this one enough. Below is a list of common interview questions. Prepare your responses beforehand and you won’t be stuck with the infamous ‘uhhh’ and ‘umm’ pit falls.
  • “Tell us about yourself.” Include major accomplishments and noteworthy characteristics
  • “What are some of your strengths?” Now is a good time to expound on and reiterate your previously mentioned characteristics. Punctual, hardworking, strong leadership and organizational skills, etc.
  • “What are some of your weaknesses?” Pick something that isn’t all that bad and put a positive twist on it. For example, I always say that I’m cursed with always being early, like an hour early, everywhere I go.
  • “How do you take criticism?” This is a big one, as we’re always dealing with other healthcare professionals who are just as tired and snappy as we are. Let your interviewer know that you take polite, constructive criticism very seriously.
  • “What would you do in a situation where a nurse is belligerent regarding delayed results?” Our job is to politely educate them on our protocol and procedures. Most importantly, reiterate your understanding that nurses are just as busy and stressed as we are and being aggressive back is not an option.
  • The Last Stretch - At this point, hopefully you’re more relaxed. Your interviewers will ask if you have any questions for them. This would be a good time to ask about opportunities you may have to climb the clinical ladder. Feel free to ask anything that’s appropriate, but not too forward. When you leave, make eye contact as you shake hands. Don’t leave in a rush, but don’t linger either.
  • Bonus note: Carry as few bags as possible. Walking into the interview fumbling with a jacket, your phone, and a purse or briefcase makes you seem messy and unorganized.

Keep these points in mind for your next interview and don’t be afraid to look for other commonly used interview questions and tips online! Most importantly, be yourself and let the interviewers get a feel for your personality!

 

Are You Ready to Rumble? Student Bowl Competitions

Rana Walley, PhD, MLS (ASCP)CM, ASCLS-MS President; Lee Byrd, MT(ASCP)H, ASCLS-MS Board of Directors Member

“Team A, for 5 points, what is the role of hemoglobin?” asked the Student Bowl Moderator, Lee Byrd.
“Hemoglobin carries oxygen,” answered the captain for Team A.
“Incorrect.” Came from the Hematology judge.
“Team B, you have 10 seconds to steal,” explained Mr. Byrd.
“The role of hemoglobin is to carry oxygen to the tissues and carbon dioxide to the lungs,” was the Team B captain’s response.
“Five points for Team B.”

While hemoglobin does carry oxygen, this response is not good enough for Student Bowl. As a student in 1996, I was part of the Student Bowl team for my small class of medical laboratory science (MLS) students at Baptist Hospital in Jackson, Mississippi. Our class reviewed material and practiced questions preparing for the Student Bowl. We did not win that year, but each of us did pass our American Society for Clinical Pathology (ASCP) Medical Technologist certification exam. Two of us later became program directors of an MLS and Medical Laboratory Technology (MLT) program and would bring our students to the same Student Bowl.

Louisiana and Mississippi hold a joint bi-state Annual Meeting each year with each state rotating the responsibility of hosting and planning. The highlight of the meeting for students is the Student Bowl Competition. There are MLT and MLS competitions. This competition is a double elimination with winners walking away with not only bragging rights, but also an engraved plaque to pass on from team to team each year. Student Bowl has been roaring at this bi-state meeting for over 40 years. The first competition was held in 1975.

Lee Byrd, a graduate of University of Southern Mississippi and longtime supporter of students, organizes the MLT student bowl. Mr. Byrd was involved in Student Bowl when he was a student over 20 years ago. He organizes binders with questions and answers for moderators and judges and updates questions as technology changes and advances. He also coordinates teams and outlines the competition bracket. Representatives from Louisiana organize the MLS Student Bowl. This year the MLS Student Bowl coordinator for the bi-state Annual Meeting was Rosalie Hendrix, a microbiologist.

Student Bowl begins with a coin toss to decide which team will answer questions first. The first round consists of a 5-point question. The moderator reads the question twice and the team captain has 30 seconds to confer with the team members and answer to the panel of judges. There is no penalty for answering incorrectly. The second round of questions contains a 10-point question for each team. The third round is when the game gets exciting. Teams may choose a 5- or 10-point question. There are no penalties for a wrong answer. However, the opposing team has 10 seconds to answer correctly and win the points. Rounds of play in eight different categories continue in a game that lasts 20 minutes or until a team scores 70 points. 

Each year at the bi-state meeting, there are two rooms for the MLT Bowl and four rooms for the MLS Bowl. Each room has a moderator and panel of judges. Each competition room also has a timekeeper, scorekeeper, and a sergeant at arms. Once a round of game play begins, no one may leave or enter the room. Volunteers step forward each year to contribute to a successful Student Bowl. Educators, graduate students, alumni, and community supporters come together each year to support students. 

Student Bowl Competition practice is a fun and effective way to study for the ASCP Board of Certification (BOC) exams. For many students, Student Bowl Competition is the first time they experience the number of professionals entering the field with them. Most importantly, students can assess their readiness to sit for the ASCP BOC exam. Student Bowl questions are tough and guide the students toward the material on which they need to focus their studies.

The comradery and excitement of Student Bowl inspires students to have a deeper passion for laboratory medicine and sparks a desire to pass that on through education.

 

Proposed Bylaws Amendments

The ASCLS Board of Directors is recommending the following changes to the ASCLS Bylaws. These amendments will be discussed and voted upon at the House of Delegates meeting to be held Thursday, August 2, 2018, at the Swissotel Chicago. 

Background: For the last two years, ASCLS leadership, including the board, and the membership, policy and procedures, and bylaws committees have been working on a reforming the membership dues structures and the governance structures aligned with them. Leadership identified a number of shortcomings with the current system, which had evolved organically over many years. These bylaws amendments, along with changes to existing policies (see related article) clarify the membership classes, aligns them with the House of Delegates and Board of Directors structures, and brings congruence with the Forums and those eligible to join and lead them.

Words with strikethroughs are deletions. Words that are underlined are additions. Where there are inconsistencies in naming conventions, the amendments voted on the latest take precedent.

Amendment 1: Changing Membership Class Names
Rationale: Changes in this section address changes to the naming conventions for membership classes and clarify what benefits are available to each class.

Emeritus Members: Currently, there are a significant number of members who are eligible for the lower dues and other benefits associated with this membership class. However, many choose not to take advantage because they continue to be involved in the profession (some continuing to work on a part time basis) and feel the name “emeritus” reflects an inaccurate image of disengaging from the profession. For those that have devoted so much time and effort over their lifetimes to ASCLS and the profession, this membership should celebrate these members’ contributions and reward them. Changing the name to “Platinum Professional” and removing the requirement that the person be retired from “gainful employment” allows ASCLS to provide a reward for our most loyal members.

Collaborative Members: This class was originally designed for those with other society memberships, but this has been unpractical to maintain appropriate records assuring membership in other societies is maintained. Still, a need exists for a simpler, lower cost membership with a narrower set of benefits for people who simply want to stay up to date on what is happening in the profession. Currently, less than 300 individuals take advantage of this type of membership. 

New Professional Members: ASCLS experiences a significant drop off in renewals from First Year Professional Members who receive discounted membership dues in their first year out of school to the second year when they become regular professional members and their dues increase. Earlier this year, the ASCLS Board approved extending these lowered dues levels for up to five years for those new graduates. This now aligns this membership category to the definition of “New Professional” in the ASCLS governance structure. A revised name shifts the focus from their transition into the profession (“new”) to their development as professionals, which is the goal of ASCLS membership.

Student Members: ASCLS wants to build a sense of professionalism in its members from the moment they enter school. Renaming the student membership to one focused on the growth of these individuals into the profession through their current educational settings (“Developing Professional”) establishes that sense of professionalism from the very beginning.

ARTICLE III — MEMBERSHIP

A. Membership
Membership in this Society is open to all persons interested in the clinical laboratory sciences and shall consist of the following classes: professional, collaborative community, emeritus platinum, student developing, ascending, and honorary. The Board of Directors of the Society shall from time to time review the classes of membership with the qualifications and the rights and privileges of each.

B. Membership Classes
The general qualifications for each class of membership are as follows: Each category of membership requires that the individual be a member of a constituent society. For each category of membership:

1. Professional
Professional membership shall be open to all persons certified or engaged in the education process and/or the practice of the clinical laboratory sciences, including those with an active interest supporting the goals of this Society;

2. Collaborative Community
Collaborative Community membership shall be open to all persons. who currently hold membership in any other health related membership organization.

3. Emeritus Platinum
Emeritus Platinum membership shall be open to any member who has retired from gainful employment achieved a minimum standard of continuous membership and age.

4. Student Developing Professional 
Student Developing Professional membership shall be open to any person enrolled in a program of clinical laboratory studies;

5. Honorary
Honorary membership shall be awarded by vote of the House of Delegates in recognition of outstanding service or contributions to the field of clinical laboratory science.
 
6. First Year Professional Ascending Professional
Ascending Professional membership is open to any student member or individual eligible for student membership, upon completion of requirements for Pprofessional membership, if the individual has not held previous membership other than Student Developing Professional or Ascending Professional membership in this Society and is within five years of graduation from a program of clinical laboratory studies.

C. Rights and Privileges

1. Professional and FYP Ascending Professional members are entitled to all rights and privileges to include voting, holding office and serving in any formal capacity recognized by the Society.

2. Emeritus Platinum Professional members are entitled to all the rights and privileges of the Society to include voting, holding office, and serving in any formal capacity recognized by the Society associated with that class of membership held at the time of application for emeritus membership. 

3. Student Developing Professional members are entitled to serve as voting members of the House of Delegates when serving as official delegates from a constituent society, and to have all other rights and privileges of the Society with the exception of holding elective positions.

4. Collaborative Community and honorary members are entitled to defined all the rights and privileges of the Society with the exception of holding elective or appointive positions and serving as voting members of the House of Delegates.

Amendment 2: Appointment of the New Professional New Member Director
Rationale: The current arrangement for transition from Student Director to New Professional New Member (NPNM) Director is problematic. There is no requirement that the Student Director be in the final year of their undergraduate program. Under the current Bylaws, it is possible that a Student Director more than a year away from graduation, could move into the NPNM Director position, but not be a New Professional, nor be eligible to join the NPNM Forum. The revised language parallels that used for the Student Director. As a past chair of the Forum, it is also believed that a more experienced board member would bring a fuller understanding of the Forum’s issues to the Board of Directors.

Article IV, B The Student Director, if eligible, shall move into the position of New Professional and New Member Director and the Student Forum shall elect a new Student Director. 

The New Professionals and New Members Forum Chair, if eligible, shall move into the position of New Professional and New Member (NPNM) Director upon completion of the one (1) year Chair term. The New Professionals and New Members Forum shall determine the qualifications for the NPNM Director.

Amendment 3: Changes to Board of Directors Representative Names
Rationale: Brings the names of the representatives on the Board of Director in line with the names of the membership classes.

ARTICLE IV – BOARD OF DIRECTORS
B. Composition
The number of voting directors shall be sixteen (16) — the President, President-elect, Secretary/Treasurer, Past President, and ten (10) Regional Directors elected by the House of Delegates in a manner prescribed by the Board of Directors of the Society. There shall be one (1) voting Student Developing Professional Director elected by the Student Developing Professional Forum of the Society and one (1) New Professional and New Member Ascending Professional Director.

Each director shall serve a term of three (3) years or until a successor is elected with the exception of the Student Developing Professional Director and the New Professional and New Member Ascending Professional Director who shall serve for a term of one (1) year or until a new Student Developing Professional Director is elected. The Student Developing Professional Director, if eligible, shall move into the position of New Professional and New Member Ascending Professional Director and the Student Forum shall elect a new Student Developing Professional Director.

A board member may be eligible for re-election, except the New Professional and New Member Ascending Professional Director, but may not serve more than two (2) consecutive terms. The House of Delegates shall elect by majority vote the appropriate number of directors each year at its annual session.

All directors at the time of their election, with the exception of the Student Developing Professional Director and the New Professional and New Member Ascending Professional Director, must have been a Professional or emeritus Platinum Professional member of the Society for five (5) consecutive years immediately prior to their election.

The Student Forum of the Society shall determine qualifications for the Student Developing Professional Director. 

Amendment 4: Changes to House of Delegates Representative Names
Rationale: Brings the names of the representatives on the Board of Director in line with the names of the membership classes.

ARTICLE V – HOUSE OF DELEGATES
C. Each duly charted constituent society shall be entitled to at least four (4) delegates [two (2) delegates-at-large, one (1) new Ascending Pprofessional, one (1) student Developing Professional delegate] plus one (1) delegate per each 50 Pprofessional, Ascending Professional and Platinum Professional emeritus members or major fraction thereof to the House of Delegates, to be designated in accordance with established procedures.

Each delegate, or a duly authorized alternate, and each member of the Board of Directors in attendance at the annual meetings of the House of Delegates shall be entitled to one (1) vote.
 
Two-thirds of all duly authorized and properly certified delegates must be present for the meetings to constitute a quorum of the House of Delegates. The House of Delegates shall act by majority vote unless a higher percentage is specified in the Articles of Incorporation, Bylaws or other applicable law.
Note: It is technically possible to accept changes to the membership classes without changes to the HOD delegates. However, congruence of terms throughout the document is preferred.

Amendment 5: Renaming Forums and Bringing Congruence to Structures
Rationale: This amendment renames the Student and New Professional New Members (NPNM) Forums to align with the new membership classes. The amendment also narrows the focus of the NPNM Forum to just new professionals. The Society’s leaders believe that the needs of those entering the profession are different than established professionals who may be joining ASCLS later in their careers. By narrowing the focus, the Forum can focus on the needs of those entering the profession for the first time. The change will align the Forum with representation on the Board of Directors and the House of Delegates, as well as the class of membership. One other change aligns the governance structures of the two forums to reduce confusion. 

ARTICLE X – SOCIETY FORUMS
A. Student Developing Professional Forum of the Society
1. The Student Developing Professional Forum shall coordinate the involvement and interest of students of clinical laboratory science in this Society.
2. The Student Developing Professional Forum shall be governed by guidelines, which shall be submitted to approved by the Board of Directors of this Society for approval.
3. A Pprofessional or Platinum Professional emeritus member of this Society, appointed by the President of the Society with the approval of the Board of Directors shall serve as an advisor to the Student Developing Professional Forum.

C. New Professionals and New Members Ascending Professionals Forum
1. The New Professionals and New Members Ascending Professionals Forum shall engage and facilitate the involvement and interest of New ascending professionals and new ASCLS members in this Society.
2. The New Professionals and New Members Ascending Professionals Forum shall be governed by guidelines, which shall be approved by the Board of Directors led by elected officers and appointees as outlined in the Standard Operating Procedures.
3. An advisor shall be appointed to the New Professionals and New Members Ascending Professionals Forum for a term of three (3) years.