ASCLS Today

ASCLSToday Masthead 680

Volume 31, Number 2

Biosafety and Biosecurity – Is Your Lab Prepared?

Linda Goossen, Ph.D., MT(ASCP)
Chair, ASCLS Government Affairs Committee

The recent international occurrences of Ebola and Zika viruses have reinvigorated the national interest in biosafety and biosecurity in medical and research laboratories. The term “biosecurity” has been used in different contexts and has acquired different meanings for people with different backgrounds. WHO and the American Biological Safety Association define “Biosecurity” as the protection of microbial agents from loss, theft, diversion or intentional misuse. Biosafety refers to the reduction of exposure of laboratory workers and facilities to potentially hazardous and infectious agents and protection from the diseases produced by these hazardous materials.  One term deals with security and the other deals with safety.1 Biosafety and biosecurity programs share common components. Both are based upon risk assessment and management methodology; personnel expertise and responsibility; control and accountability for research materials including microorganisms and culture stocks; access control elements; material transfer documentation; training; emergency planning; and program management.” 2 
 
At the April 14 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC), Toby Merlin, MD (Director, Division of Preparedness and Emerging Infections, CDC) and Reynolds Salerno, Ph.D. (Division of Laboratory Systems, Center for Surveillance, Epidemiology and Laboratory Services, CDC) presented current biosafety challenges our laboratories face. These challenges include the fact that “changes in demographic, environmental, and cultural trends have made outbreaks of emerging and reemerging Infectious disease more common” and thus we can expect that laboratories will have to contend with more outbreaks of infectious disease in the future. As a result, we need to be able to provide better biosafety guidance and support to clinical laboratories. However, there is currently a lack of professionals with laboratory biosafety knowledge and experience, a factor resulting in delays in hiring Biological Safety Officers (BSO). 
 
Evidence of the biosafety gaps in the U.S. can be found in the CDC Rapid Ebola Preparedness Team report from their assessment of U.S. readiness to treat Ebola patients From October 2014 through January 2015, the CDC REP teams evaluated 55 hospitals for their ability and preparedness to receive, identify, and treat patients with suspected or confirmed Ebola virus infection. 
 
As reported by Nancy Cornish, M.D. (Medical Officer, Division of Laboratory Systems, CSELS, CDC), the assessment showed that “laboratory staff were not always conducting risk assessments, following OSHA’s  blood borne pathogens standards, or implementing safe work practices; laboratory instruments were not necessarily safe for operators; there was a lack of communication between the lab and clinicians; there was insufficient training in work practices and personal protective equipment (PPE) and a lack of data on safety of routine clinical laboratory procedures for Ebola specimens.” In addition, the team reported that some professional organizations recommended that laboratories limit testing in their regular clinical laboratories on Persons Under Investigation (PUI) for Ebola and some national reference laboratories requested that clients not submit specimens from PUIs for Ebola.
 
Furthermore, in 2013, researchers at UCLA published results of a survey of almost 2,400 scientists on attitudes about safety. Approximately half the respondents had experienced injuries in the lab and 30% had witnessed a major injury. Of the U.S. respondents, only 25% conduct formal risk assessments and 50% assessed risk only “informally.” The survey also revealed that safety standards are often not adhered to and “only 60% said they had received safety training on specific hazards or agents they worked with.” 3 
 
The question remains of how we can ensure clinical laboratories are well prepared for emerging infectious diseases and biological threat. CLIA regulations 42 CFR Part 493.1407(e)(2) and 1445(e)(2)charge the laboratory director with ensuring that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. Regulation 493.1101(d) states that safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Thus, we need to ensure that laboratory directors are aware of their responsibilities for providing a safe environment for their employees. We are also responsible for proper education of our laboratorians to increase their knowledge, skills, and abilities to guarantee a safe working environment for all. Training and education of laboratory staff must begin early; including laboratory safety in the curriculum for undergraduate and graduate programs is essential. Education of laboratory staff must include PPE requirements and engineering controls available for use in the lab, including biosafety cabinets, splash shields, and closed instrumentation. 
 
In her Keynote presentation at the ASCLS 2015 Annual meeting, Dr. Cornish asserted that risk assessment is the basis of a laboratory safety program. Risk assessment is a 5-step process of identifying the hazards (agents, procedures, and staff), evaluating the risks, determining controls, implementing controls, and evaluating the outcomes. The assessment should include pre-analytic, analytic, and post analytic processes. For the assurance of safety from biological agents, the assessment must include personal protective equipment (PPE), and determine if it is appropriate for the activity and if the staff has been trained and are comfortable with its use. Biosafety Cabinets must also be assessed to ensure they are being used and maintained properly. 
 
The bad news for laboratories is that labs are very short staffed and working on biosafety issues is a low priority, leading to a lack of fundamental knowledge about biosafety in the lab community and weak biosafety culture. Most clinical labs have never performed a risk assessment. The good news is that multiple agencies are currently focused on developing programs and protocols to encourage a culture of biosafety and biosecurity in our nation’s laboratories.  
 
For example, the American Public Health Laboratories “was awarded a $2.2 million cooperative agreement in the spring on 2015, with the CDC to assist public health laboratories strengthen biosafety and biosecurity practices and to develop guidance and tools to support public health laboratory outreach to sentinel clinical laboratories formed a biosafety and biosecurity committee” 
 
The objectives of the committee include the following:
  1. outreach to public health laboratories to assist these labs with implementing the activities outlined in the CDC’s Epidemiology and Laboratory Capacity for Infectious Disease Cooperative Agreement,
  2. delivering training via workshops, webinars, and other modalities on packaging and shipping of infectious substances ad conducting risk assessments,
  3. creation of online forums to facilitate information sharing among biosafety professionals at public health laboratories,
  4. creation of a repository for new and existing biosafety and biosecurity tools and promoting their use,
  5. establishment of a Biosafety and Biosecurity that will develop biosafety and biosecurity guidance material, address policy issues, and design tools to support risk assessments in both public health and clinical facilities. 
 
In April 2015, CLIAC recommended to the U.S. Department of Health and Human Services that the department provide oversight that ensures that biosafety training and assessment is required of all CLIA-certified laboratories, including personnel responsible for the pre- analytic, analytical, and post-analytic phases of testing; ensure oversight, input, and resources into studies evaluating the safety of all laboratory practices, instrument testing, so that studies are sound, robust, evidence-based and applicable; and develop a process for investigating and reporting laboratory acquired infections. 
 
ASCLS has also made our voices heard regarding the nation’s biosafety and biosecurity preparedness. In comments addressed to CLIAC in 2015, we stated “While the latest infectious disease outbreak (Ebola) raised a number of questions about the occupational health and safety risks faced by everyone in healthcare, we should all be familiar with how to protect ourselves and our patients from biological hazards presented by exposure to infectious agents… OSHA standards and CDC guidelines when used, and used correctly, are very protective and effective.  Admittedly complacency sets in and the risk assessment process that CDC is promoting is an excellent way to educate and re-educate laboratory professionals.  We hope that CDC will partner with all professional organizations to disseminate credible education… We believe this is a great time for the clinical and public health laboratorians to work together to address our issues, and to implement a strong safety culture throughout all sectors.” 
 

References

  1. Biorisk management Laboratory biosecurity guidance. World Health Organization. September 2006, WHO/CDS/EPR/2006.6
  2. Biosafety in Microbiological and Biomedical Laboratories, p 104. CDC. 
  3. Richard Van Noorden, “Safety Survey Reveals Lab Risks,” Nature 493, pp9-10; 02 January 2013 

What the Gurus Want You to Know About Drawing Coags

Dennis J. Ernst MT(ASCP), NCPT(NCCT)

Millions of patients are on blood thinners to prevent blood clots that can lead to stroke and other life-threatening complications. Because laboratory tests are critical to determine and monitor their dosage, drawing their blood regularly is essential to their well-being. Yet those who draw and handle their samples can easily and unknowingly alter the test results, leading to unnecessary and dangerous adjustments in their dosage. Do you know the multitude of ways in which you might unwittingly be misleading physicians into improperly medicating their patients? If you're a manager, does your staff know?

Phlebotomy Today recently polled three coagulation gurus in the laboratory industry for what they would most like anyone who draws coags to know to ensure all patients on blood thinners are properly medicated.

"Pre-analytical variables account for about 64% of coagulation errors," says Donna Castellone, supervisor of the Special Coagulation and Hematology department at New York Presbyterian-Columbia hospital in New York City. "So we want you to know a lot about drawing blood for coagulation testing. Everything starts with phlebotomy – garbage in- garbage out! Every improperly collected or handled sample can mean delayed surgery, additional testing or a change in medication."

Castellone can't underemphasize the importance of filling coag tubes properly. "With more and more automation, techs see less and less of the tubes prior to testing. They might not get rejected in the lab, so reject them at the point of collection. If you don't, it will impact your aPTT result. So, no underfilled tubes. This is really, really, really important.... Really!"

George Fritsma, MS, MT(ASCP), coagulation author, consultant, and purveyor of The Fritsma Factor, agrees. "An under-drawn 'short' specimen generates unreliable hemostasis results, so fill the tube to the fill line. Those who draw coags should not overfill the tube, either." He also warns of the risk of underfilling when collecting through an infusion set (butterfly needle).

"The tubing of the device delivers approximately 0.5 mL of air into the tube, causing a short draw," says Fritsma. He recommends applying a discard tube first, which may be another light blue-stopper citrate tube, but not a tube with another additive. "Plastic red-stopper or serum separator tubes contain particulate activators that can be transferred to the citrate tube."

Both gurus also concur on the importance of mixing citrate tubes immediately. "Telling people to mix well seems simple," says Castellone, "but if you don't, it will impact results. We don’t need frothing, just a nice mix." Fritsma joins the chorus by stressing tubes should be gently inverted 3-4 times to prevent clot formation, which makes coag results unreliable. He cautions against vigorous mixing, which hemolyzes red blood cells.

Fritsma also wants those who draw coags from existing IV lines to realize doing so often ruptures red blood cells, which is visible as pink to red plasma. Because hemolyzed specimens generate erroneous results for most laboratory tests, he discourages line draws. "If there is no other choice, collect blood slowly to reduce turbulence and lower the risk of hemolysis." Fritsma also stresses the importance of collecting and discarding 5 mL of whole blood to clear possible contaminants, then collect the hemostasis specimen.

Traumatic venipunctures are also a concern to Castellone. "If you have a difficult draw, it should be noted. You can activate factors with the introduction of tissue factor, and the results for screening tests may be artificially decreased, and factors increased."

Fritsma and Castellone not only want you to know the collection errors that threaten accurate coag results, but they're equally adamant that you know the handling errors that wreak just as much havoc on patient care. 
"Getting samples to the lab quickly is critical," says Castellone. "You only have a 4-hour window for the aPTT, and for patients on heparin it's only one hour. So get those samples to the lab ASAP."

Fritsma echoes her sense of urgency. "Immediately transport the hemostasis specimen to the laboratory at room temperature. Do not refrigerate them or place them on ice, and don't expose them to temperatures over 26oC. Chilling and heating both cause rapid specimen deterioration. Centrifuge and separate specimens that are collected to monitor heparin within one hour of collection."

For Castellone, how the labels are applied by the collector is something that often gets overlooked. "Labels... oh boy! If they are too thick they get stuck in the racks, if they overlap we can’t see patient information. Seems like a simple thing, but I have ruined more nails trying to scratch off labels to get info!"

Fritsma adds "Everyone who draws coags, or any sample for that matter, must label the tube with the patient’s full name, medical record number, and the date and time of collection while at the patient’s side. "And don't forget to follow the proper order of draw to prevent another tube's additive from carrying over into the coag tube, which could alter test results."

Fritsma hopes those who collect and handle coag samples realize they should observe the site for bleeding after the draw. "Many hemostasis patients take blood thinners and may require several minutes of post-venipuncture supervision and pressure bandages to prevent puncture site bleeding." He also states specimens for platelet function assays are never centrifuged or refrigerated, and testing must be completed within four hours.
Castellone recognizes the importance of phlebotomists and other healthcare professionals on getting good coag samples to the lab. "We appreciate all that you do, and how you help us start with a good sample, which is a really, really, really big deal!"

Participate in the conversation on ASCLS Connect and the Phlebotomy Scientific Assembly.

Reprinted with permission from Phlebotomy Today. © Center for Phlebotomy Education, Inc. Dennis J. Ernst MT(ASCP), NCPT(NCCT) is the director of the Center for Phlebotomy Education in Corydon, Indiana.

 

NPNMF Spotlight Brocksmith

The New Professionals and New Members Forum is showcasing a member who exhibits pride in ASCLS, demonstrates hard work, and has excellent leadership skills. For this issue, we would like to spotlight Gretchen Brocksmith. 

Gretchen received her Bachelor of Science Degree in Biology from the University of Louisiana at Lafayette in 2008. She began working at Exxon Refinery in Baton Rouge and wanted more out of her career. Her mother introduced her to Clinical Laboratory Science (CLS) and before she knew it, she was enrolled at Our Lady of the Lake College in Baton Rouge in CLS. She completely fell in love with Clinical Laboratory Science. She finally felt like this is where she belonged and could finally make a difference in someone’s life.  

At the LA-MS Bi-state convention, a friend nominated her for the Louisiana Student Forum Chair. This is where she found her love for ASCLS and her passion for laboratory science grew significantly. Since then, she has held positions at the State, Regional, and National levels. She has attended the Legislative Symposium twice and the National Meeting 3 times. Philly was her 4th time!! 

She has found a zeal for government affairs and a love for being a voice for our Society. She enjoys being an advocate for students, new professionals, and new members. ASCLS has given her great opportunities and opened many doors for her. Being a part of a Society has taught her how to be a team player, how to be a leader and how to be follower. More importantly, it has shown her we truly care about our profession by putting the patient first, we uphold safe laboratory practices, and report out quality work. Currently, Gretchen is the 2016 New Professionals and New Members Forum past Chair, Leadership Academy graduate, in the Membership Program, a member of DAC, and New Professional for GAC. 

Gretchen is now living in Metairie, LA where she works in the Hematology Laboratory at Ochsner Medical Center in the New Orleans. Ochsner is the #1 Liver Transplant hospital in the nation. She volunteers for many activities Ochsner offers such as King Cake Festival where kids and adults alike enjoy king cake from all over the city and play games for prizes. She also helped collect and sort can goods for Second Harvest. This year, for Lab Week, she was on the laboratory committee and contributed to the games, prizes, and food for all lab professionals in the hospital. 

She is a very social person. She enjoys going out and meeting different and new people. She is not afraid to introduce herself to you. She also loves the outdoors. Some of her hobbies include running, biking, and weightlifting. She also enjoys hiking and swimming. She absolutely loves going to the beach. Some of her goals include volunteering more not only at her hospital but in her community as well. 

Student Forum Leadership 2017

As the 2016-2017 ASCLS Student Forum Officers we would like to introduce ourselves.

Greetings!

My name is Savannah McPherson, and I will be serving as your 2016-2017 Student Forum Chair. I am thrilled to be able to serve ASCLS in this capacity but also to serve you, the future of Clinical Laboratory Science(CLS). I was eager to join ASCLS as soon as I became a CLS student at Virginia Commonwealth University in August, 2015, having enrolled after realizing CLS was a perfect blend of science and service that appealed to my kinesthetic nature. So far, I have been able to serve the Clinical Lab community as a Student Ambassador for our local society: Richmond Society for Clinical Laboratory Science, the President of my CLS Class, a tutor for my program, and as a Health Committee member focused on point-of-care test administration for a low-income population through the VCU/MCV Wellness Block Party. I have enjoyed being able to travel with my school to talk about CLS to High School and College students looking for their future career paths, and I hope to continue doing so well into the future. Outside of lab, I enjoy relaxing by watching cartoons, drawing and doodling, taking long drives just listening to music, hiking, making paper crafts, and baking. You are the future of ASCLS and the Laboratory Community, so remember that the choices you make now, especially in the face of the changing political and legal realm surrounding the profession, will shape that future. I look forward to serving you and will work hard to make sure 2016-2017 is a great one!

Hello student members of ASCLS! 

My name is Nicole (Niki) Buza and I am honored and excited to become your 2016-17 Student Forum Vice-Chair. I began my involvement with ASCLS in 2013 during my internship for my MLT degree and have been lucky to grow my leadership abilities through ASCLS as both a student and new professional. I received my phlebotomy certificate in 2010 and my A.A.S. as an MLT in 2013, both from Northcentral Technical College in Wausau, WI. I knew from my Lab Skills class that I wanted to become a lab tech. I’ve been working as a generalist MLT since my graduation and absolutely LOVE this profession. I’ve also always had the desire to teach and, therefore, I need to continue to learn and grow as I aim for that goal. I am finishing my Bachelor’s degree through UW-Stevens Point and completing my clinicals at the UW-Health University Hospital in Madison, WI. Since joining ASCLS I was given the amazing opportunity to serve last year as the ASCLS Region V Student Forum Representative and the ASCLS-WI Student Forum Chair. This year my leadership roles will include: Student Forum Vice-Chair, Phlebotomy Scientific Assembly Chair, ASCLS-WI New Member/New Professional Forum Chair, and also a student member of the Promotion of the Profession committee. If you want to get more involved in the organization, please don’t hesitate to ask how – we’re here to help and be your go-to people. There are amazing opportunities all over ASCLS, so make sure you take a chance and go for them - I promise that you won’t regret it!

Hola a todos!

I’m Maria Rodriguez, and am honored to be serving as your Student Forum Secretary and Region VIII student Rep. I am originally from Venezuela, but I have been in the States since 2013. My decision of pursuing a CLS/MLS career goes back to when I was 10 years old. My cousin was misdiagnosed with Leukemia and it was too hard for me to see him suffer. With my degree, I want to seek for a way to improve diagnosis of diseases that affect people in poverty and lack of awareness from communities like the one I lived in. I am pursuing my dream at Montana State University, where I am also pursuing a Genetics minor and a Leadership certification. Joining ASCLS was the best decision I could’ve made. ASCLS opened so many doors for me and it has given me the opportunity to serve the clinical laboratory community. Outside of the CLS/MLS, I love getting involved with my community; in fact, one of my goals every semester is to dedicate 80 hours to community service. During my college career, I have been fortunate enough to find wonderful mentors who welcomed me into their Lab, where I have been working on heavy metal exposure and its effects in epigenetics modifications. As an officer of the Student Forum, I hope I can be there to guide students into the best resources of this field. I also would love to reach out to mentors, instructors and professors and let them know that, as students, sometimes we need an extra push. Don’t underestimate the power of mentorship!