generalist – Page 22

The ABCs of BSCs

Many labs have received notices this year that their Biological Safety Cabinet (BSC) certification company will no longer certify a certain type of BSC that those labs have had for years. NSF International (formerly the National Sanitation Foundation) is an organization that supplies product testing, inspection and certification. NSF is accredited by the American National Standards Institute (ANSI) to develop American National Standards, and in 2010 an updated version of the NSF/ANSI 49 was published. This is better known as the Biosafety Cabinetry: Design, Construction, Performance, and Field Certification standard.

The names can be confusing, but the important message is the revisions to the standard eliminated the option of direct-connected Type A cabinets (which had been previously allowed). Also, an alarm requirement was added for canopy connected Type A cabinets. There was time allowed for sites with these types of BSCs to make necessary adjustments, and in 2016 field certification agencies have been told they can no longer certify BSCs which do not meet the updated standards.

That means that some labs that have not updated their BSCs or purchased new ones, they are left with uncertified (and therefore unusable) cabinets.

There are three main classes of BSCs. Class I offers the least amount of protection, and it pulls air in and over the work area. The air is then exhausted via a HEPA filter. Class II BSCs are the most commonly-used cabinets in clinical laboratories. They offer a maintained inward airflow, a HEPA-filtered unidirectional airflow within the work area, and a HEPA-filtered exhaust into the room or to the facility exhaust system. Class III BSCs (or glove boxes) are for use with high risk biological agents, and they are typically sealed and gas-tight enclosures.

The commonly-used class II cabinets come in a variety of designs or types:

A1 – 70% of the air recirculates through the supply HEPA filter, the other 30% of air goes through the exhaust HEPA filter.
A2 – 70% of the air is recirculated through the supply HEPA filter, the other 30% of air goes through the exhaust HEPA filter. The air intake is faster than in a type A1 cabinet.
B1 – 40% of the air is recirculated, 60% of air is exhausted.
B2 – No air is recirculated within, it is all exhausted into the facility system.

Some older Class II Type A cabinets had the exhaust directly connected to the facility exhaust system. This is no longer permitted since hard connections need to meet specific regulated criteria and is not considered the safest type of connection. If connected to an exhaust system, the cabinets must use a canopy (thimble or air-gap) connection which has an opening to the room. Because there is always the potential for equipment failure (and a possibility of air contamination to the room via the opening), an alarm system must also now be in place to alert the user of this possible danger. In 2016, all BSC field service workers were notified not to certify Type A cabinets with a hard connection or with a non-alarmed canopy connection. If you received a memo and had an issue with certification this year, that’s why!

No matter what Class II type of BSC you are using, there are some basic safety guidelines every user should know in order to keep protected while working. If the blower is not kept on all the time, turn it on about ten minutes before use. This will stabilize the protective air flow in the cabinet. Adjust the seat height so that the user’s face is above the front opening. Set all specimens and materials that are needed inside the work space, and separate the clean from the dirty. Do not set anything on the front grille. Objects too close to the front, side, and rear air grilles can disturb airflow and compromise the specimen and the worker’s safety.

When working in a BSC, avoid frequent and fast motions. When moving arms in and out of BSC, move them slowly and perpendicular to the sash. This will allow less interference with the air flow. Be sure to limit traffic in the area when working- people walking behind a BSC in use will disturb the air flow such that air will pass out of the cabinet into the breathing zone of the user. In general, fume hoods and BSCs should never be located in high traffic areas.

Once work is completed inside the BSC, properly dispose of all waste material. Disinfect the cabinet surfaces using an extension apparatus to reach the back wall. Never put your head inside the BSC. Use a bleach solution for disinfection. If damage to the surface is a concern, wipe down the surface with water after using the bleach. Let the BSC run for at least 10 minutes before turning off.

It is important to remember that a Biological Safety Cabinet is an engineering control designed to protect the worker, but it only does so if used properly. Make sure all users are properly trained to use a BSC safely. Have them certified annually, and let certified professionals perform the required maintenance. If you received a memo this year, it may be time to purchase a newer BSC in order to maintain safe work practices in your lab. Ask your field service representatives for the best option for your laboratory.

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-Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

An Arbovirus Abroad

Hello! My name is Constantine Kanakis and I am very happy to contribute to Lab Medicine’s online blog! As my first post, I would like to introduce myself, tell you a little bit about my interests in laboratory medicine, and also discuss Zika virus research I’m actively involved in.

I studied molecular biology at Loyola University and medical laboratory science at Rush University, both in Chicago. From undergraduate to graduate school, I was fortunate enough to work on research topics involving the neurology of nematodes, enzymatic plant assays, social justice/urban planning work, microbiological lab equipment development, and novel biochemical hematopoietic interventions. This comprehensive experience in research work provided a strong foundation which I have found useful in my career both in and out of the hospital laboratory. Other than research, I spent nearly nine years working in some of Chicago’s busiest hospitals. I learned the ropes in a variety of settings: trauma center transfusion medicine, academic center quality assurance, public health work, and community hospital laboratory work. I feel personally drawn to laboratory medicine and pathology, as it connects translational research to patient outcomes and puts us in a position to mobilize fellow professionals to improve health care in our communities.

This bridge from lab discoveries to bedside and beyond motivated me to write for this blog community. The current Zika virus outbreak as well as the start of my medical school career has provided a great opportunity for me to explore translational research and its direct impact into a local community. Currently, I am a second year medical student at American University of the Caribbean School of Medicine located on the island of Sint Maarten, in the Netherlands Antilles (Figure 1). I find myself in the epicenter of the now infamous viral epidemic of everyone’s new favorite Arbovirus: Zika. Studying in the Caribbean, I am actively involved in projects assessing the emergence of this viral phenomenon. Today, CDC lists countries with active infections with a Level 2 travel active warning notice, “[to] Practice Enhanced Precautions.” These projects have three tiers: laboratory studies, collaboration with local health partners, and integration of research with public health efforts. My location here provides ample opportunity to gather information at its source, most notably from our neighbors in Brazil, Puerto Rico, and even Florida. This island is high on the list of endemic countries with 1,730 suspected Zika cases reported as of July, 2016, however only 12% of those cases were serologically confirmed. The suspected cases have been rising in the last few months (Figure 2) and epidemiologists are watching the trends very closely.

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Figure 1. The Centers for Disease Control and Prevention (CDC), updates regions on the world map which have reported active Zika virus infections, CDC 5 October 2016.

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Figure 2. Suspected Zika viral infection cases per epidemiological week, Pan-American Health Organization (PAHO) and World Health Organization (WHO) 2016.

As a primer for those who are interested, the Zika virus is a Flavivirus/Arbovirus undergoing its second recent epidemic spread in the last decade. Discovered in the 1950s, it has been considered a minor viral infectious agent. To date, researchers near and far are exploring both potential vaccination and prevention measures, as well as infection control efforts as some claims link the virus to microcephaly, Guillain-Barre, and other various sequale. It is transmitted primarily by mosquito bites directly into the blood, though its antigenic presence has persisted in urine and even seminal fluid. Research in public health and epidemiology has also related the management of this outbreak to previous ones, including that of the 2014 Ebola epidemic. There is contention between various public health organizations and laboratory researchers in detailing any exact correlation of the viruses secondary effects as well as the difficulty in specific detection and diagnosis relative to reported vs. confirmed cases (Figure 3).

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Figure 3. A general demonstration of the purported Zika infection cases and how this reflects the true nature of the epidemic in the Caribbean in collaboration with the PAHO and WHO, from the Caribbean Public Health Agency (CARPHA) 2016.

Several research projects are starting here on campus, a majority of which involve serologic prevalence and surveillance studies. Some new studies are aimed directly at using commercially available testing, while others compound data from previously significant outbreaks of other arboviruses (e.g. Chikungynya, Dengue, Yellow Fever, West Nile). Our work in the laboratories here is also matched with significant public outreach. I am involved in one particular service and outreach project through the university here which targets the dissemination of Zika prevention/infection knowledge through various informational outlets such as town hall meetings, health drives for children, and vector control projects in the field. Our school-based task forces have been fortunate enough to form partnerships with the local Ministry of Public Health, Social Development, and Labor here on the island. And, coordinating with their Collective Prevention Services, they are now involved in reaching out to the community at large (see Figure 4).

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Figure 4: One of the newest school projects sponsored this year included a vector control initiative partnership with the Sint Maarten Red Cross, and the Ministry of Health’s Collective Prevention Services, conducting home inspections in areas of statistically high reportable cases, photo credit: A. Yancone 2016.

On a personal note, I will add that my wife and I, along with several of our friends here have ironically been “bitten by the Zika bug.” We all suffered the same relative symptoms (fever, malaise, myalgia, headaches, and the infamous maculopapular rash), so I can speak personally on the effects of an active Zika infection! Really though, it isn’t that bad; it felt like a bad flu—most locals are not too worried about Zika because they already have several other arthropod-borne viral infections to stay away from with significantly worse courses of infection. Chikungynya, Dengue Fever, Yellow Fever, West Nile, less often Plasmodium/Malaria, and others offer more of a threatening presence than the several day woes of a Zika infection. Moreover, those other infections sometimes have even worse complications and clinical presentations.

As I begin and continue my work through these projects, I will provide updates—both on our efforts here in the laboratory as well as our work in reaching out and partnering with local public health officials to try and make a positive impact on our local community. And since I am now “inoculated,” I’ll be happy to get really close to the action for all of you.

Thanks for reading!

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-Constantine E. Kanakis MSc, MLS (ASCP)^CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student at the American University of the Caribbean and actively involved with local public health.

The Lonely Life of a Clinical Pathologist: Joining Committees

My first rotation in pathology was at a smaller community hospital; one of the pathologists there used to say, “If you aren’t at the table, you’re on the menu.” I’m not sure the source of this quote, but his point was good pathologists are involved with different committees in the hospital system, not only to contribute to the well-being of the institution, but to let them know how the laboratory could be of assistance, or if the items they were discussing were not feasible from the laboratory standpoint. This also ensured that any decisions made did not negatively affect the laboratory.

When I started working as a pathologist, it felt like before I could even put my bag down the microbiology coordinator was introducing me to the infection control nurse, whom requested I be a part of the infection control committee. My original plan had been to ease into my position and not over-commit myself, rather just observe the first year and then decide where I could best be utilized and dedicate my focus outside the lab. However, I figured infection control would be a great place to talk microbiology so I went to the meeting and was added to the members list that day. The involvement in this committee has led to some great relationships and changes in our labs. The infection control staff had a difficult time with our C. difficile assay since it was performed as a batch test, leaving their patients in isolation for up to 24 hours after submitting specimens. By attending these meetings I was able to see how the lab could implement a change and we brought in a different assay that had random access for C. difficile. This helped improve patient care, and strengthened the relationship between infection control staff and the laboratory. Since that time, I have gotten involved in a couple of other in-house committees on an ad-hoc basis. The involvement has allowed me to actively participate in other areas of the hospital and make connections with staff and physicians to see how the lab can best serve our patients.

In addition to the in-house committees, I was asked to participate in corporate laboratory service group that includes members of each corporate affiliate in our system. This committee discusses laboratory issues that affect the corporate system as a whole and has a sub-committee for test utilization. This committee was very active in laboratory utilization and gave me great information and a strong foundation to start from on how our own institute could implement some of these standards. For instance, there was a drive to remove sedimentation rates from most order sets and replace with CRP. This topic gave me a purpose to interact with other clinicians within our institution and talk about how these changes will affect lab results, ultimately the care of their patients, and get everyone on the same page.

While my year of ease and observation did not become a reality, the mentor I had in medical school’s advice did. Being involved with these committees has really shown me that by being at the table as a laboratory representative, we have a voice for how issues will affect patient care.

How about you – what has been the best committee you have gotten involved with? How are you sitting at the table? I look forward to hearing how others have been the voice for the laboratory.

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-Lori Racsa, DO, is the director of microbiology, immunology, and chemistry at Unity Point Health Methodist, and a Clinical Assistant Professor at the University Of Illinois College Of Medicine at Peoria. While microbiology is her passion, has a keen interest in getting the laboratory involved as a key component of an interdisciplinary patient care team.

Facing CJD and Prion Diseases in the Lab

According to the National Institute of Health (NIH), Creutzfeldt-Jakob disease (CJD) is a rare, degenerative, fatal brain disorder that affects about one person in every one million people per year worldwide. In the United States there are about 300 cases per year. Some of us know the ailment better as “Mad Cow disease,” but that is only one form of this illness which is not caused by a virus or bacteria. CJD is a prion disease. A prion is a protein that exists in both a normal form, which is a harmless, and in an infectious form. The infectious form of the protein takes on a different folded shape, and once these abnormal proteins appear, they aggregate or clump together. Investigators think these prion aggregates may lead to the neuron loss and other brain damage seen in CJD. However, they do not know exactly how this damage occurs.

Since laboratory professionals may deal with specimens from possible CJD patients, we need to know how to properly handle them should such a situation arise. If the Operating Room calls your labs to process a brain biopsy specimen from a patient who was suspected of having a prion disease, would you know what to do? Can your lab do that? Should your lab do that?

Prions are dangerous, but CJD cannot be transmitted through the air or through touching or most other forms of casual contact. Prion transmission can occur, however, from contact with highly-infectious specimens. Brain tissue, eye tissue, and pituitary tissue are considered high-risk specimens, and contact with these should be avoided. When asked to handle a brain biopsy, medical staff and safety experts should work out a plan. For instance, a lab tech who is trained in Category A packaging could go to the OR, dress in fully protective PPE (including a body suit, gloves, and hood), and receive the specimen in the OR and package it there. The specimen is then ready for transport to the reference laboratory. If another department asks you to handle tissue samples from a suspected CJD patient, stop everything and escalate the issue immediately. Contact your medical director, your manager, or the safety officer and await further instructions.

There are other specimen types a lab might receive from a prion patient. Blood, serum, urine, feces, and sputum are considered no-risk specimens. Prions are not found in these types of specimens, and they may be handled and processed as usual.

The last category of specimens from prion patients is known as “low-risk.” These specimens include CSF, kidney, liver, spleen, lung, lymph nodes, placenta, and olfactory epithelium tissues. Of course the most common specimen a lab would see from this group is a spinal fluid, and labs do need to make sure they do not handle it as a normal specimen.

Lab staff should be notified when a specimen is going to be sent from a prion patient, particularly when a low-risk specimen like a CSF is on the way. Procedures should be in place, and it is recommended that such specimens have special labels on them to alert those of the potential risks.

There is no record of lab employees becoming infected with prions from handling low-risk specimens, but they must still be handled with care. All testing of low-risk specimens should be performed inside a Biological Safety Cabinet (BSC). Use disposable equipment as much as possible. For example, use disposable cups for stains or reagents where possible. Perform manual testing only; do not run low-risk specimens on automated analyzers as disinfection is not easily accomplished.

While using standard bleach solutions to disinfect surfaces is recommended after processing low-risk specimens, a lab spill of such a specimen is an entirely different matter, and this is why lab specimens should have special labeling. When a low-risk specimen spills, the area should be flooded with 2N Sodium Hydroxide (NaOH) or undiluted sodium hypochlorite (bleach). Remember, never mix bleach with formaldehyde as it produces a dangerous gas, so if a pathology specimen is spilled, only use NaOH. Leave the solution on the spilled material for one hour, then rinse with water. Place the spill materials into a sharps container so that they will be incinerated. If a spill of a low-risk CJD or prion specimen occurs, contact a manager, a medical director, or the safety officer immediately.

Laboratory professionals handle infectious specimens every day which is why it is so important that we utilize Standard Precautions. Wear PPE when working in the lab and treat all specimens as if they were infectious. It’s the only way to prevent a lab-acquired infection. If you see a co-worker not wearing gloves or a lab coat and working at a lab counter or computer, use coaching to remind them that those surfaces are potentially contaminated with pathogens, and they can be deadly. We can protect ourselves from low-risk prion disease (and other pathogens) with everyday PPE. If a specimen is processed in the lab and it is found later the patient was prion-positive, you do not want to be the one who wasn’t wearing PPE when you handled the specimens. The results will be potentially disastrous for you and your family.

Remember, if you receive a phone call that a CJD or prion specimen is being sent to the lab, escalate the situation immediately. Find out if your lab is able to receive and process that type of specimen. Protect yourself, and keep your lab safe from CJD and other infectious pathogens.

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Local is Global

The words “global health” usually triggers thoughts of exotic diseases in exotic locales. But, we should remember that “global” includes our own backyard! Public health and clinical laboratories and lab professionals in the US play an important role in global health efforts, just as labs and lab initiatives in remote, resource poor areas. Labs are important for healthcare at local, national, and international levels. Without labs, we risk antimicrobial resistance, spread of infectious diseases, environmental exposures, and inadequate management of chronic non-communicable diseases like diabetes.

Despite their significant role in healthcare, our labs at home face funding and staffing challenges. It is estimated that 7,000 medical technologist positions need to be filled annually, and only 6,000 are produced each year. The number of training programs have decreased by 15% since 1990. CMS has recently announced that a bachelor’s degree in nursing is equivalent to a degree in biological sciences required to perform high-complexity testing. While nursing education provides invaluable medical knowledge, it does not include in-depth scientific study of principles behind laboratory testing and technology.

Both clinical and public health labs in the US are facing financial challenges. Public health labs, especially, have functioned on minimal budgets for several years. With these challenges, maintaining status quo can be difficult let alone scaling up activities when needed for managing crises. We see this play out with the Zika virus. The CDC has already spent 87% of funding allotted for Zika. State public health labs are worried about their ability to continue to meet routine needs while scaling up to be able to perform Zika testing. The FDA recommendation for screening donated blood products puts additional burden on laboratories and blood banks.

The reason we don’t think of our own backyard when we hear “global health” is because we don’t have as many of the exotic diseases seen in other locales. This is in large part because we do have quality laboratory systems in place. While in the field, comments such as “I had no idea pathologists did this much” have been made to me. As lab professionals we need to advocate for laboratory medicine, at home and abroad.

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-Sarah Brown, PhD, DABCC, is an Assistant Professor of Pediatrics and Pathology and Immunology at Washington University in St. Louis School of Medicine. She is passionate about bringing the lab out of the basement and into the forefront of global health.

The Lonely Life of a Clinical Pathologist: Rounding with the Clinical Care Team

A recent article in Critical Values by Dr. H. Cliff Sullivan (Claiming Our Seat at the Cool Kid’s Table: A Rallying Call to Pathologists) discussed how pathologists can be a part of the clinical care team but it is a hard job to complete when we are isolated to our offices or laboratories. One of the recommendations by Dr. Sullivan was to engage fellow clinicians in whatever way we can as pathologists. For this blog post I want to talk about one task in particular that has allowed me to be involved with clinicians: clinical Rounding.

When I first started my job, the most senior pathologist and critical care chair asked that I round in the intensive care unit once a week with the clinical team, consisting of nurses, mid-level providers, residents, pharmacists, and attendings . I am sure my face conveyed my baffled thoughts: what could I offer by rounding in the ICU and more importantly, how will I have time for that? However, being a new pathologist, who was I to say no to my boss and the ICU chair? I might be bold on occasion, but not that bold. The first day I arrived for rounds (still wondering what I would be doing, hoping they would not ask a question I did not know the answer to) a question came up about a susceptibility report: the mid-level provider did not understand how an isolate could be resistant to piperacillin but susceptible to piperacillin/tazobactam. It was a perfect way to impart pathology knowledge to the clinical team. As I continued to round on a weekly basis, question after question would come up – what does it mean if an HSV PCR is negative in a cerebrospinal fluid; why are peripheral smears not reported out at certain times; what does this new LIS Sunquest do differently and why is it so slow; what do you think about an alpha-fetoprotein level of 27; what is the mechanism of ADEM? These questions were sometimes very easy to answer and at other times I needed to do more investigation. In addition to answering questions on rounds, these times spent in the ICU have built up relationships; it puts a face on the name of the laboratory and has allowed the team members to reach out to me on different occasions even when I am not “rounding.”

Over the past year I have found that this one undertaking that I was so uncertain of how I could contribute to has now been one of the constant reminders of why I chose clinical pathology as a profession. While these clinical team members might not understand what I do on a daily basis, they all have one goal in mind: providing the best patient care. I like the role of being a consultant and being able to contribute to medical discussions and I have always known that laboratory results can define patient care but attending these rounds has given me first-hand experiences of how the laboratory truly affects patient care. It has been apparent through these interactions how important it is to have someone involved on the patient care team that understands the laboratory and can shed light about why the assay the provider wants to run may or may not be appropriate or why interpreting specific test results based off other confounding factors is so vital. While being a clinical pathologist may be lonely in the fact few people perform my exact job, however being involved with the clinical care team absolves that loneliness and has reminded me that each role has their place in medicine.

Now to hear from you – how do you interact with clinicians outside of the lab? Have you found a way to round with other interdisciplinary teams and if so, what has been the best approach?

Thanks for reading!

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Challenges in Transgender Healthcare

Transgender healthcare is a topic that doesn’t get a lot of attention. Healthcare providers receive little to no formal training in this area, and this population is one of the most under served groups in the United States. The authors of the recent Lab Medicine paper Challenges in Transgender Healthcare: The Pathology Perspective wrote a blog on this topic for Oxford University Press. Check out obstacles in transgender healthcare to learn some of the issues providers and patients face.

The Lonely Life of a Clinical Pathologist: Rounding in the Lab

As I mentioned last month, a big part of my job has been to do daily rounds through the lab to seek out areas that need troubleshooting. One point I noticed was technologists don’t always see the impact of their work on patient care. I wanted to make sure they knew the importance of their work so I decided to incorporate education as a tool to highlight how their work directly affects patient care. Each section of the laboratory has their own ways of communicating so I have done something a little different in both labs.

In the microbiology section, I started a weekly “formal” microbiology rounds with the infectious disease doctors, the pharmacists, and the technologists. While I saw this rounding at both of my training institutions, there were held in different styles. In one, the infectious disease team rounded through the lab and asked the techs questions about their patients; in the other, the team discussed interesting case around a microscope. I decided to take a combined approach: we meet in the lab at the microscope so the techs can work if needed yet still be a part of the discussion. The techs save interesting cases that have come up over the last week or so and we show the rest of the team. It usually involves discussing organism identification methods as well as the disease process associated with the organism. This has given the techs the chance to ask the physicians and pharmacists questions about the patient isolates they have worked on directly. In addition, it has given them the opportunity to ask why physicians order certain tests. The pharmacists have added so much to these rounds and it has been nice to see a collaborative effort between multiple areas of the patient care team come together and talk about why things are done and the outcome of the patient based on laboratory results. It demonstrates to everyone that each member of team is passionate about patient care. In order to bring some of this knowledge to the second shift staff that performs microbiology processing, I save one or two interesting cases from rounds and present a quick rundown of what the bug is and how it is identified in the lab so they can see how their work is completed the next day.

For chemistry and immunology, the laboratory team has a monthly meeting. At each of these meetings, I run through a formal case presentation based off interesting cases the techs have come across or have had questions on specific disease processes related to the laboratory work they are performing. The topics have ranged from beer potamania (that got a lot of discussion!) to what polymerase chain reaction is. It has been another approach to show the technologists how their work directly impacts patient care and they have really enjoyed it. The goal is to bring clinicians into these discussions, as well, but that has not been as easy for these meetings. We have been able to bring a pharmacist in to discuss vancomycin trough levels and why draw times are so specific. It really helps having other departments reach out to the laboratory staff to let them see why policies are structured the way they are.

I really enjoy being in the lab and interacting with the technologists, however, one of the principal lessons I have learned this year is how important it is to get out of the laboratory as a clinical pathologist. The next couple of months I will talk about how I have gotten involved in other areas of the hospital. But for now, let’s hear from you, do you have any formal rounding or education that you offer your techs? What ideas have had the best responses from the technologists? I am looking forward to hearing more ideas on how to integrate education and interdisciplinary teamwork for our laboratory staff.

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-Lori Racsa, DO, is the director of microbiology, immunology, and chemistry at Unity Point Health Methodist, and a Clinical Assistant Professor at the University Of Illinois College Of Medicine at Peoria. While microbiology is her passion, she has a keen interest in getting the laboratory involved as a key component of an interdisciplinary patient care team.

Elizabeth Holmes Presents New Technology at AACC2016

Yesterday, I had the opportunity to attend the Theranos presentation at the AACC 2016 meeting in Philadelphia. While several outlets have already reported on it (Wired did a particularly good job with their write-up), I wanted to give a few of my thoughts as a laboratory professional.

Holmes didn’t present information or data on their Edison platform. Instead, she presented on a whole new tabletop device called the MiniLab.
Essentially, the MiniLab is just that–it’s one machine that performs (dozens? hundreds? that part is unclear) tests on patient samples. It appears to be a counter-top sized analyzer, and will be able to perform chemistry, hematology, and immunology tests from one sample.
Most of the data presented was performed using the MiniLab and venous blood samples.
While the box is indeed small and all-inclusive, non of the tech inside–at least, as far as I could tell–was revolutionary or groundbreaking in anyway.
There seems to be a lot of waste. The cartridge includes the consumables to do dozens of tests, but what if a patient only wants, say, a CBC performed?
I’m finding it hard to believe that this analyzer would make laboratory testing affordable. Accessible, maybe, but it’s not going to be cheap.

If you’d like to see the presentation and the Q&A, you can watch it on YouTube.

If you’d like to see the slide deck with Holmes’ presentation, it’s here..

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-Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

FDA Halts Blood Donation in Two Florida Counties Due to Zika Virus

From the Washington Post:

“In a notice sent to blood centers and posted on the agency’s website Wednesday evening, the FDA said it is requesting all blood centers in Miami-Dade and Broward counties to ‘cease collecting blood immediately’ until those facilities can test individual units of blood donated in those two counties with a special investigational donor screening test for Zika virus or until the establishments implement the use of an approved or investigational pathogen-inactivation technology.”