The Lonely Life of a Clinical Pathologist

Have you ever felt like no one knows exactly what you do for a job; friends, family, even your colleagues? As a clinical pathologist, if you are ever asked what your job entails, it might take you a full 10 minutes to just explain the surface of it and by that time your audiences’ s eyes have glazed over and they are wondering when their next coffee break is.  It can get pretty lonely when very few people understand your daily life of work.

I currently hold a general clinical pathology position and oversee the microbiology, chemistry, and immunology sections of a community hospital laboratory that services two hospitals totaling a little over 500 beds.  I also get consulted on point of care testing and consult at two critical access hospitals that have a general AP/CP pathologist directing their lab.

As a new clinical pathologist, I was asked to blog about my experiences during the first year of working in the real world. I thought it would be a great venue to talk about how I have combatted the “loneliness” I face when I feel like no one knows what I do. Over the next couple of months I will highlight some of the tasks I have undertaken in my current position and I’d also love to hear what other clinical pathologist’s careers look like and/or how they have evolved over the years.

The beauty of a career in clinical pathology was explained to me by an attending during my residency training –you make of it what you want to.  He also told me to not venture into the lab because they will ask you to do things, and since I am not very good at following advice, that is exactly the first topic I would like to explore: getting into the lab on a daily basis.

When I was in training, one of the best ideas I took away for my job was microbiology rounds. The first attending I observed holding these was a medical microbiologist that would round through the micro lab every day asking the techs if they had any odd cultures, questions that needed to be answered or anything that required follow up.  When I took this job, I knew I wanted to incorporate this type of rounding as part of my work.  My office is conveniently located at the back of the microbiology laboratory, so as I walk through the lab, I make it a point to say hi and ask the technologists if they have any issues, or any interesting cultures. It is not a formal rounding, but issues come out of these interactions and give me items to follow up with on a daily basis.  Having my office located in the lab also allows the techs to come to me throughout the day with any questions they may have and has established a great rapport between us.

I also round through the chemistry and immunology section of the lab, specifically hitting second shift, as they lack a lot of interaction with clinicians. This has been a harder task for me because my subspecialty training was microbiology. I feel comfortable interacting with the technologists and lab staff, but when I first started I had the fear that I would not know the answer to a question I might be asked.  Lucky for me, there are not as many questions that come out of these rounds. But of the questions I have gotten and I did not know the answer, it has never been a problem by me saying “I don’t know off the top of my head, but let me get back to you”.  It also helps that I drop off candy in the break room while they wait on me – it is truly amazing how chocolate helps you make friends (thanks for the tip, Mindy Kaling). In addition to troubleshooting, rounding through the lab has given me the opportunity to interact with other people who have a passion for laboratory medicine. The techs will get just as excited about an interesting organism that was isolated or a new instrument we might bring in, and it is great to be able to share that passion you feel for your job with others.

Next month I will discuss a little more about the “formal” interactions I have set in the lab, but for now, let’s hear from you: how do you get involved in the lab and the technologists you work with?

 

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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.

 

Your Survival is in an Undisclosed Location

Over on NPR, Nell Greenfieldboyce writes about secret bunkers filled with healthcare supplies. You know, for the upcoming zombie apocalypse. (Okay, or maybe the next flu pandemic). It’s an interesting look at the logistics that go into managing stockpiles. Also, the author points out a sobering thought: while so much planning goes into inventory, dispersing that inventory in the event of an emergency could prove to be an issue.

 

Special Safety Considerations in the Anatomic Pathology Laboratory

Margie had worked in the histology department for years. She never used the chemical fume hood when pouring formaldehyde, but lately she had been coughing quite a bit, so she decided it was time to use the hoods. Soon she would be diagnosed with lung cancer.

Steve was a cytotechnologist working in the radiology department for a fine needle aspirate procedure. The radiologist was in a hurry, and when he handed the uncapped sample needle to Steve, the needle pierced the skin in Steve’s hand. The patient had Hepatitis C.

Jane had finished her long day of assisting with frozen sections and had to clean the cryostat. It was the end of the day, and she wanted to go home. She reached into the cryostat to change the blade with her gloved hands. She received a nasty cut on her finger, and since the blade had been used for multiple patients, Jane had to be treated for an exposure from an unknown source.

Anatomic Pathology laboratories present unique safety concerns that can differ from clinical lab concerns. Formaldehyde and other hazardous chemicals are used to preserve tissue specimens, workers can be exposed to large amounts of blood and body fluid during autopsies, and the sharp blades in cryostats and microtomes create additional cause for concern. Histology and Cytology employees need to be ever-vigilant to protect themselves from these exceptional hazards.

Formaldehyde and xylene are two chemicals typically handled in the AP lab. Xylene is a strong-smelling flammable liquid, and formaldehyde is listed by OSHA as a known carcinogen. If using these chemicals in the lab, you should have specific safety procedures for them, and vapor concentration monitoring should be performed to determine employee exposure levels. It is important to review the monitoring results as soon as possible, and never more than 10 ten days after receiving them. Discuss the results with each monitored employee individually or post the results in the department. Because monitoring is performed for tasks as well as locations, it is considered representative monitoring. That means one result may represent several employees who perform the same tasks or work in the same area.

If vapor concentration levels are elevated, make sure to take measures (such as using engineering controls) to reduce or eliminate staff exposure. OSHA’s Formaldehyde Standard requires annual monitoring if results are above the STEL (short term exposure limit). To discontinue sampling, the lab needs to obtain results from two consecutive sampling periods taken at least 7 days apart show that employee exposure is below the action level and the STEL.

OSHA requires a specific safety formaldehyde training for all employees who are exposed to formaldehyde concentrations of 0.1 parts per million (ppm) or greater. This formaldehyde training must include specific elements including education of the contents of the Formaldehyde Standard, the contents of the formaldehyde Safety Data Sheet (SDS), the health hazards of formaldehyde exposure, the proper use of necessary PPE, and spill response and clean-up procedures. This training is required by OSHA annually, and it may need to be provided to some employees who work outside the laboratory (operating room staff, labor and delivery staff, etc.). Even though the laboratory may not be responsible to provide this training, it is a good idea to communicate with other department leaders to ensure they get the required training for their staff.

Blades and other sharps pose great risks in AP procedure areas. Most microtomes and cryostats are equipped with knife guards- insist that they be used. Remove used blades with magnetic-tipped implements and insert new blades using rubber-tipped tweezers. Place disposable knives in sharps containers after use.

Odd as it may seem, there are Cytology procedures where the hand-off of uncapped needles containing samples sometimes occurs. Unprotected needles should never be passed from one person’s hand to another. These needles should be placed on a counter or the technologist should only take them from the collector with an implement such as tweezers. Be sure there is ample space to safely perform the cytology tasks in the procedure area away from the lab.

Laboratory Safety is not a “one-size fits all” umbrella for all areas where laboratorians work. Risk assessments and task assessments are critical to determine the particular hazards in a specific lab. In the Anatomic Pathology laboratory, these assessments should guide safety leaders to those specific safety measures which can help your staff prevent injuries and exposures which can be career and life-changing.

 

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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.

altona Diagnostics Receives Emergency Use Authorization for Zika Virus Diagnostic Test

On May 13th, altona Diagnostics received Emergency Use Authorization (EUA) from the FDA for their RealStar Zika Virus RT-PCR Kit U.S. for the qualitative detection of RNA from Zika virus in serum or urine (collected alongside a patient-matched serum specimen) from individuals meeting CDC Zika virus clinical criteria. This is the same kit that Houston Methodist Hospital and Texas Children’s Hospital used for their laboratory-developed Zika test.

FDA Letter of Authorization

altona Diagnostics press release

 

CDC’s Interim Guidance for Zika Virus Testing

In their most recent Morbidity and Mortality Weekly Report (MMWR), the CDC issued interim guidance for Zika Virus testing. From the report:

“On the basis of the newly available data, CDC recommends that Zika virus rRT-PCR be performed on urine collected <14 days after onset of symptoms in patients with suspected Zika virus disease. Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected <7 days after symptom onset. A positive result in either specimen type provides evidence of Zika virus infection.”

 

Anatomy of a Safety Stand Down

In March of 2016, the United States Government Accountability Office (an independent agency that works for Congress) produced a report stating that stronger oversight mechanisms are needed to improve safety in high-containment laboratories. The laboratories referred to are those which work with hazardous biological agents in order to protect public and animal health and the food supply against contamination of those agents. Because of several very public lab safety lapses in the past two years, the report makes 33 recommendations to improve lab safety. These recommendations include the development and update of policies that contain missing safety elements, the reporting of oversight activity to senior officials, and the development of plans with time frames to implement the safety recommendations. The report basically recommends a “Safety Stand Down.” Has your laboratory seen a similar situation? Have you encountered a series of like safety events that created the need to stop and review?

OSHA’s definition of a safety stand down is “an event for employers to talk directly to employees about safety.” Because of the danger to employees, a more specific definition means that all work stops until the issue is corrected and all affected (or potentially affected) staff has been educated to make sure the issue does not re-occur. However, in the real world, unless someone is in imminent danger, the work of the laboratory must go on for the sake of patient care. Still, a stand down can be important, and there are ways to run one successfully.

Once you have decided there is a need for the stand-down, develop the stand-down education. This can include a set of presentation slides, a hand-out, or talking points to use as the information is delivered. Make sure you stick to the topic(s) at hand, and do not include extraneous information, but be certain to include all items that are pertinent to the stand-down subject.

The next step is deciding on the stand-down delivery approach. Will you meet with staff one-on one, in small groups, or with everyone at the same time? Choose the meeting location(s) and schedule the meetings. Because this is a stand-down and a safety issue that must be dealt with, these steps should occur quickly. If you are facilitating the stand-down but not delivering it personally, be sure to give a short deadline for its completion and mandate that all involved personnel are included. Keep documentation of attendance and subject matter for future reference.

Once the stand-down is completed, gather the documentation of attendance and any other associated information and keep it for your records. This does not end the stand-down, however. Make a plan and a schedule to follow-up on the safety issue. The plan may include daily or weekly checks to ensure new processes are being followed or that staff has understood the information completely.

Conducting a laboratory safety stand-down can seem difficult and time-consuming. It may interrupt the work you planned to do, and it may change your schedule for the next couple of days or weeks. While that may be inconvenient, remember that this course of action was chosen to help prevent harm to employees or patients, and that is what laboratory professionals are here to do.

During the week of May 2, 2016, OSHA called for a construction fall prevention safety stand-down. This was in response to a high number of preventable worker deaths due to falls on the job. What safety issues have you seen in your lab? Have you seen multiple needle sticks? What about slips, trips, and falls? If you notice a group of similar safety events, it may be time to conduct a safety stand-down. If you deliver the information, provide the education, and document the attendance of all affected staff, you will prevent further injury and continue to raise awareness in the lab of vital safety issues.

 

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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.

The Final Countdown

As June 1 rapidly approaches, I hear many questions about OSHA’s final deadline in its implementation of the Globally Harmonized System (GHS) for the classification and labeling of chemicals. For laboratories in the United States, this journey began in 2013 when the first training deadline arose. All employees who work with chemicals were required to have training on the changing chemical label elements and the updated and standardized Safety Data Sheets (SDS).

Helpful Hint: Neither you nor your staff should be writing or saying “Material Safety Data Sheet” or “MSDS.” Those are outdated terms and should no longer be used. Unlike the old versions, the new SDS are standardized with 16 uniform sections that are the same no matter which chemical manufacturer provides the information.

The 2013 GHS training provided a good amount of information, and it raised many questions. Will manufacturers really be using pictograms and signal words to identify hazards? Would they truly be able to make those changes by the next deadline dates? How does that affect secondary chemical container labeling? What about changes to the lab’s chemical hygiene plan and signage? It was a great deal to absorb and digest.

The year 2015 held within it two more deadlines that would affect all laboratories. First, chemical manufacturers would have to create only products which contained GHS-compliant labels, and they would have to produce only GHS-compliant SDS. OSHA realized that these manufacturers would have a substantial amount of non-compliant inventory at this point, so there was a six month period before the next requirement would be enforced. That meant these companies would have six months to continue delivering non-compliant chemicals and SDS to laboratories. The second deadline in 2015 was the cut-off period for these manufacturers. They would no longer be permitted to ship chemicals with non-compliant labels or SDS. The last deadline would also provide a six month gap. OSHA has given laboratories time to accept and use these chemicals with non-compliant labels.

Helpful Hint: Walk around your laboratory and look at all of your primary chemical container labels. If you find any that are not GHS-compliant, you need to remove them from your lab before June 1 of this year. OSHA does NOT allow the re-labeling of primary chemical containers.

The final GHS implementation deadline, June 1, 2016, requires that labs complete the updates of all workplace labels, Safety Data Sheets, and any hazard communication policies and procedures. The lab Chemical Hygiene Plan should be updated to include newer terminology and labeling instructions. The chemical inventory may need updating as well to include signal words or pictograms if used on that form. While this last deadline has an impact on primary chemical container labels, it does not need to affect secondary container labeling. OSHA does allow the continued use of NFPA or HMIS labels for secondary containers in the lab provided staff is trained on those hazard warning systems as well.

Helpful Hint: For consistency and better staff understanding, choose one labeling convention for secondary chemical containers in the lab. Using GHS and NFPA/HMIS may be confusing. Labeling is an important piece of hazard communication, and staff needs to be clear on what hazards they may be handling.

Some signs in the lab may need updating in certain areas. Buried in OSHA’s Formaldehyde Standard (1910.1048) is a GHS reference that points to a required wording change. If the formaldehyde warning sign is posted in your lab, the GHS implementation requires updated wording. The sign is required in labs where the formaldehyde concentration exceeds OSHA’s limits as detected via vapor badge monitoring. The updated signage must read as follows:

DANGER

FORMALDEHYDE

MAY CAUSE CANCER

CAUSES SKIN, EYE, AND RESPIRATORY IRRITATION

AUTHORIZED PERSONNEL ONLY

The full implementation of the Globally Harmonized System is here, and it is a modern system designed to adequately communicate hazards to those who work with chemicals. Many countries around the world have been or are in the process of adopting GHS, a system which provides standardized warnings and information. Once fully implemented in your laboratory, these updated chemical hygiene practices will assist in providing an environment for working with chemicals that is both comprehensible and safe.

 

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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.

FDA Allows Experimental Zika Virus Test

From the press release:

The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.