In 1962, Marvel Comics introduced a new super-hero in their comic book titled “Journey into Mystery!” That character would become famous both in the book and eventually on the big screen. He was the mighty Thor. Through the years this Norse god of thunder would have many adventures and travel into many strange and unusual places all to protect his home of Asgard and to save the people of his adopted home planet, Earth. While the character of Thor willingly chose to journey into those many unknown places, those who work in the laboratory with bloodborne pathogens should not.
Evan popped the tops off of the serum separator tubes and placed them into the analyzer rack. He used a counter-mounted shield to protect himself from a splash. He picked up the rack containing five specimens and walked over to the chemistry analyzer to run them, but as he neared the analyzer his grip loosened, and he dropped the rack. It fell about an inch onto the analyzer and serum splashed up into Evan’s eyes. He did not know from which tube or tubes was the source of his exposure.
Rose was running late when she started her shift in the histology grossing lab. She did not notice that the small sharps container for scalpel blades was over full at the bench. When it was time to change her blade, Rose reached up without looking to eject the blade into the sharps container. She felt a sharp pain and saw that she had cut herself on several used blades that were sticking up out of the container access hole. Her injury had to be treated as an unknown source exposure.
If a bloodborne pathogen exposure occurs in the lab, there are several regulations that should be in place to help protect the exposed employee. OSHA’s Exposure Control Plan includes hepatitis vaccinations for employees, and follow up source testing instructions to discover the HIV and hepatitis status of the known source patient. Prophylaxis for an HIV exposure in the lab must be administered quickly to be effective, usually within 2 hours of the exposure, so rapid testing is key.
There are, unfortunately, accidents that occur for which the bloodborne pathogen source cannot be determined. The incidents described above could have been prevented, and they should have been, because treatment for an unknown source exposure is a journey no ne should want to make. In some cases, like with the sharps exposure, it is impossible to determine the source. In other cases, as with a rack of tubes, it is too costly and there is no time to test all possible exposure sources.
In some facilities, after an unknown source exposure, the policies call for complete serological testing of the exposed victim for HIV and hepatitis. This does not provide useful information, however, it only provides the serological status before the exposure, it does not alter the necessary treatment.
Treatment for an unknown source exposure usually consists of the immediate administration of prophylactic drugs. While these drugs are designed to help prevent the post-exposure development of HIV or hepatitis, they are known to be toxic to the body and can have many ill effects. Personal consequences can occur as well after such an exposure. As a precaution, the exposed victim may be told to avoid intimate relationships for six months. Clearly, this is not a journey anyone would willingly want to take.
All exposure incidents in the laboratory setting should be prevented, and the majority of them can be prevented easily. Pay attention to the surroundings and look for potential sources of exposure. Consistently use proper PPE including face protection whenever handling open specimens or performing maintenance on an analyzer where tubing or reservoirs are involved. Empty sharps containers when ¾ full, and never allow anyone to open them or dig through them, even for a lost specimen. The risk is too high.
In many ways, the work of a laboratorian should be a journey into mystery. There are test results to produce, diagnoses to be made, and new techniques to discover. With the work in the lab environment, all exposure risks should be assessed, and they should be mitigated using engineering controls, safe work practices, and PPE so that this work can be performed safely. Let the scientific mysteries be those that prevail and not the scary alien consequences of an unknown source exposure.
–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.
One of my favorite older horror movies is The Shining. The acting, the music, and the pace of the story create a good long scare for the audience. In one scene, the mother and child are playing in an outdoor maze constructed of tall bushes. Later in the film they would be running for their lives in that selfsame maze, but I do not want to give away any spoilers if you haven’t watched it. The maze sometimes reminds me of some laboratory departments that I have seen, and I have seen how winding hallways and multiple doorways create confusion for lab employees and others in the facility.
The International Organization for Standardization (ISO) states in its standard Medical Laboratories — Requirements for Safety (ISO 15190:2020) that clean and dirty areas need complete separation from floor to ceiling. For example, the break room must be a completely separate room from the space where lab work is performed. While not all laboratories are ISO-certified, this is clearly an infection control and safety best practice. The Occupational Safety and Health Administration (OSHA) has been known to enforce this when they cite labs for incomplete separation of clean and dirty areas.
The Centers for Disease Control (CDC) published its resource, Biosafety in Microbiological and Biomedical Laboratories (BMBL-6th Edition) in 2020, and it requires a hand hygiene sink near the exit of laboratories so that hands can be washed before exiting the department. That means door handles inside the department must be considered clean and not touched with gloved hands.
Think about those requirements and apply them to your lab space(s). Do they work? Do they make sense to you? If you work in a Biosafety (BSL) 2 or 3 laboratory, you should understand the basics of pathogen containment. After all, the Biosafety Level of your laboratory is determined by the infectivity of pathogens present, the severity of disease they could cause, their transmissibility, and the nature of the work conducted. Based on risk and task assessments, labs should utilize the personal protective equipment (PPE) appropriate for the tasks performed, and that PPE should never be brought outside of the laboratory (another OSHA regulation).
One of the most common questions I receive from lab safety professionals is how to improve PPE compliance. The answer is, we need to make it easy for our staff to do the right thing. That means providing education so they understand the consequences of unsafe behaviors, and it means putting practices in place that make sense and are easy to follow.
In my travels I have seen labs that require that gloves must be removed before touching lab telephones and keyboards. I have seen specimen transport policies that allow for the use of wearing one glove for holding specimens and keeping the other hand clean to touch doors, and I have also seen staff who are told to keep a glove on to touch all lab door handles. If your staff are required to figure out that crazy maze of practices, they are not ever all going to get it right, and someone is going to acquire an infection.
If you require all gloves to be removed and hands to be cleaned before exiting the lab (as you should), are there sinks and waste cans at the exits? If lab coats must be hung up before going into the break room or rest room (as they should be), do you provide coat hooks near those doors? If staff must leave one BSL2 lab and walk through a clean hallway to deliver specimens to another lab, what do they wear? Do they wear their PPE (violating OSHA’s regulation) and do they touch door handles with gloves that other staff will use without gloves when leaving the department for the day?
Lab Acquired Infections (LAIs) are vastly under-reported, and many time people do not even realize how they got infected. There are probably many lab practices (like the ones mentioned above) that lead to these. Could this happen in your workplace? How can you prevent it?
Start, as always, with a risk assessment. Determine the hazards in your workplace, create hazard mitigation steps, and determine if any residual risks still exist. Take a good look at your physical layout. Can a “clean” hallway be designated as “dirty?” Would something as simple as adding a door to close off a hallway make it so safety regulations can be followed? Those risk assessments and diagrams used as a show-and-tell for facility leadership can often be what gets you the approval or funds you might need to make those changes. Correcting those unsafe practices and those long lab winding hallways and exits will certainly make it easy for staff to find the way in and out while containing the pathogens where they should be.
–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.
When we enter the laboratory, we know of the dangers that can be encountered. Our training tells us there could be microbes and other potential pathogens in the samples we are about to analyze. We also learned how to protect ourselves; how our behavior while in the lab has consequences. We even know how to dress properly and what engineering controls we have at our disposal to keep us safe. We put on our personal protective equipment (PPE) before we start to work and remove it before leaving the lab. For some, these behaviors are automatic, actions that are done almost without even thinking. But is this the same for all who enter the lab? Do visitors who comes into the department know what they are really walking into or how to keep themselves safe in an environment that may be foreign to them? One common question asked by lab staff regarding visitors is “do they have to adhere to the lab safety policies and if so, why?”.
On a recent safety audit, I visited a lab that happened to be getting a new chemistry analyzer installed. I noticed the vendor team, which consisted of 5 individuals, were not wearing any PPE. There were backpacks, open water bottles, and cell phones sitting on the counters and floors. The new instrument was not hidden in a back corner of the lab far away from the daily work. It was close to the area where the lab process, spins, and runs patient samples. Members of the vendor team were lying on the floor and crawling around. How does that scene make you feel?
Vendors and service representatives are regular visitors in your lab. A laboratory can have a representative on site a dozen times before you even begin to use that piece of equipment. Once it is installed, you can bet you will see them multiple times for preventative maintenance and service calls. How does your lab welcome these guests? Do you let them in and have them get right to work? If they are there to repair an analyzer you are likely eager to have them get started, but do you ask them to wear a lab coat? Did they bring one of their own that was kept in their backpack? If so, do you think that coat is clean or was it used in a different lab, packed up, and brought to your lab? Vendor compliance is a safety issue for many labs because these visitors are not lab employees, yet they are in your department and may be putting themselves and your team at risk. Often vendors are seen with drinks in labs, using cell phones or touching instruments without gloves – behaviors lab folk are told not to follow. So why is it tolerated? It shouldn’t be, and you have the right to speak up and ask them to adhere to your lab policies.
What about other potential laboratory visitors? Do pathologists come in to look at a patient slide in Hematology? Do they just sit down at your bench and look at the slide without gloves or a lab coat? Is lab staff allowed to scan a smear without PPE? Probably not, and no one else should be allowed too either. The microscope has most likely been touched with dirty gloves, and no one else should touch the same scope without gloves. Even lab doorknobs are a consideration. Staff should wash hands before leaving the department. That means no one should use contaminated gloves to open the door.
Speaking up about these safety issues to lab visitors can feel uncomfortable. A conversation with a physician about safe practices in the lab can be daunting, but the cost of not speaking up can be high. Take the opportunity to show you care about visitors and want to keep them protected. Sometimes you know who is coming to the lab, and you feel confident they have been trained and will use the best safety practices. At other times, though, those guests may be unexpected and lacking in safety knowledge. Make sure to treat them with respect, give them the safety training and tools they need so they can leave both happy and healthy.
-Jason P. Nagy, PhD, MLS(ASCP)CM is a Lab Safety Coordinator for Sentara Healthcare, a hospital system with laboratories throughout Virginia and North Carolina. He is an experienced Technical Specialist with a background in biotechnology, molecular biology, clinical labs, and most recently, a focus in laboratory safety.
Len began his shift in the hematology department. He liked to use the counter-mounted safety shield when opening specimens because he did not like to wear goggles over his eyeglasses. When it was time to read differential slides, he knew he could not look into the microscope with his glasses on, so he reached up with his gloved hands, grabbed his frames and set them on the dirty hematology workbench next to the scope.
OSHA’s Bloodborne Pathogens Standard was promulgated (put into effect as law) in 1991. Its purpose was to prevent employee exposures to infectious organisms that may be present in blood or body fluids. For those employers covered, that meant creating an Exposure Control Plan, providing certain vaccinations, educating staff about exposure follow-up, and providing personal protective equipment (PPE).
Much has changed in healthcare since 1991, but the standard remains unchanged. Changing an OSHA standard does not happen often, and it does not happen quickly. In many ways, for the Bloodborne Pathogens Standard, that’s a good thing. The same protective measures must be in place in workplaces like laboratories, and despite the appearance of novel pathogens over the last 30 or so years, the basic required risk assessments and mitigation steps still apply.
Some people, however, complain that the standard doesn’t speak clearly enough about issues that have changed over time and that now need to be addressed. Do the regulations speak to personal electronic devices in the lab like smart phones, smart watches, and ear buds? There is mention of not having food or drink in the department, but what about chewing gum or candy? Sometimes you need to dig a bit deeper to discover that those issues are also addressed, even though some of those issues did not exist when the standard was written.
If you read the line, “Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure,” it seems very clear that OSHA is trying to prevent hand to face contact. While they did not cover every possible action, this likely includes gum chewing and touching cell phones which are then brought to the face (or worse, used at home by a toddler wanting to play). It can be argued that lab employees use telephones often on the job, and that gloved hands are near the face because of that.
So what other actions occur in your lab that could potentially create bloodborne pathogen exposure – actions that may occur every day or so quickly you don’t notice? Have you thought about wireless headsets or speaker phones in the lab? Do you look in cabinets and drawers for food or drink (especially during off-shifts)? Is gum chewing allowed in your lab (hint: if you’re in a CAP-accredited lab this is strictly forbidden)?
And what about poor Len with his glasses? Has anyone trained him to remove his gloves, wash his hands, and place his spectacles on a clean surface before using the microscope? There might be other things you did not notice. If you have an employee with hearing aids, do they remove them to answer the phone? Do some staff wear gloves when opening the lab exit door and others use bare hands? Are computer keyboards used with and without gloves? Is PPE worn into lab rest rooms? These are all instances where a lab-acquired infection could begin, and they happen in a flash. Perform risk assessments to not only locate the risks, but to implement ways to mitigate them. Magicians claim that their hands can move faster than the eye can see in order to work their tricks. Employees will perform “tricks” as well, but the outcomes may not be as entertaining. Providing safety education and observing people at work to see where other risks exist are important steps toward complying with the Bloodborne Pathogens Standard. The regulations are not new, but with updated lab policies and safety measures, they can be powerful tools to protect you and your staff from the new pathogenic threats headed our way.
–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.
Ben was excited to bring the new analyzer into the laboratory until he discovered the manufacturer’s newest security feature. Anytime a user was to log into the analyzer’s computer to diagnose issues or to perform maintenance, a unique numeric passcode would have to be entered, and that code would be sent via text to the app that staff could download on their cellphones. John knew that the use of cell phones in the lab violated the personal electronic device policy.
Emily was proud of the work she had done to design the new outpatient collection draw area. It included a row of collection rooms each with their own computer for order entry. The central area outside the rooms had a phone and printer set up for an efficient workflow. However, every time she performed a site visit she noticed her staff were using cell phones in the patient collection rooms. When she asked why, they told her they often had to make calls to clarify orders, and that talking on the central phone meant discussing patient information in front of people seated in the waiting area.
When a basic need of a human being is not met, conflict is automatically set up in the mind, and humans will deal with that conflict with a workaround or possibly with aggression. Often laboratories and their procedures are designed without considering all of the potential needs of the staff who will work there. Conflict will arise, and policies will not be followed, and you may also wind up with unhappy employees.
When it comes to safety policies and procedures, it is important to educate why they must be followed. It is vital to discuss the possible outcomes of not using safe practices. That may mean exposures to chemicals and biohazards, and it may also mean injuries. It can take time to explain that the use of a smart watch with contaminated gloves can lead to infection and potentially severe illness at work and in the home.
While this understanding is important, it must be coupled with a system of practices that allows staff to easily follow the prescribed safe practices. It must be easy for staff to perform safe acts, there should be no hindrances in their way for that to happen. Otherwise, conflict will occur, and the set policies will not be followed. Staff may know the regulations, they may even understand the potential consequences of not following them, but they will not conform to the policies because of some software glitch or because some vital tool is missing in their environment.
When you notice a lab safety violation, or if a safety incident has occurred, the first thing to look for in the investigation is something in the system that may have caused it. Unless the incident occurred because of a blatant act by the employee, blame should never first be focused on the person. What departmental design flaw exists? What engineering control could have been in place? What PPE should have been readily available? What was the temperature and humidity in the department, etc.?
Upon further discussion with the vender, Ben learned that the manufacturer’s security code system could not be bypassed, but that the app could be downloaded onto an electronic tablet rather than a cell phone. Ben purchased a tablet that could be used in the lab and remain there so as not to create any infection control issues. The tablet was also used for lab safety and quality audits so that pictures of issues could be taken and that results of audits could be entered directly. It became a real time saver, and no cell phones were needed in the laboratory.
Upon review, Emily realized that access to phones in the new outpatient collection area needed to be better. There was no way to even call or help from a collection room should there be an adverse reaction to phlebotomy. Emily was able to acquire portable phones in the short term until she could get permanently-mounted telephones into each of the three blood collection rooms. Staff no longer needed to use cell phones in the biohazardous areas.
Humans have basic needs like food, shelter, and clothing. When those needs are not met, some may act in surprising ways to obtain them. The same holds true in the laboratory. There is a need to be safe, there is a need to follow safety regulations and policies, and unsafe behaviors will arise if it cannot be achieved. Feed the safety needs of your employees. Provide a safe working environment with good engineering controls, PPE, and polices that allow for workdays that have no safety conflict.
–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.
During a recent trip to South Dakota, I was able to visit Badlands National Park. I am not a hiker or a camper, so I was not sure I would enjoy the park very much, but it turned out to be the highlight of our vacation. The vastness of the landscape and the unusual beauty of the rock formations cannot be captured in pictures. It is truly something that should be see in person at least once in a lifetime. While walking the trails of the park, it looked and felt like walking in an alien world. It looks strange, and there are hidden dangers- rattlesnakes, potential high heat, and crumbly walkways with sudden drop-offs.
The experience reminded me of how the laboratory must seem to visitors or workers who need to come into the department to perform various duties. The laboratory must seem like a foreign world, and indeed, there are many hidden dangers within. If I had walked blindly into Badlands National Park and not read the warning signs, would I have been bitten by a snake or could I have walked off a cliff? Of course. Do the signs in your lab adequately warn visitors of the dangers? Do visitors pay attention?
The lab staff reported a plugged floor drain under the hematology analyzer, so the facilities plumber arrived to repair it. He asked the staff if the analyzer was running, and because they were not processing any samples, they said it was not. When the plumber bent down to look at the drain, the analyzer cycled waste through the drain line which quickly splashed into the eyes and mouth of the plumber.
Warning signs are required in many labs for many reasons, but they are not sufficient for protection from the hazards in the department. Those who enter the “badlands” of the lab need to be told about the dangers, and they need as much information as possible. If someone is coming in to work on equipment, offer proper personal protective equipment. If someone will be on the floor of a biohazard lab, make sure a lab coat and gloves are in use, and lay a pad on the floor if possible. Make sure people understand proper terminology. An analyzer may not be actively running samples, but it is still “on,” and there are still potential hazards present.
It should not be assumed that people who come to work in the lab department will have general knowledge of the laboratory or of lab safety practices. It is a good practice to use a safety training checklist for vendors or others who enter the department and to go over that checklist at least annually. Couriers can be harmed by pathogens, chemicals, or dry ice. Phlebotomists who are expected to process samples should be trained in centrifuge operations, spill clean up and more. Environmental service workers and biomedical engineering staff need to understand the chemical and biohazards in the department.
Instrument service representatives have training, but not typically much of that training is focused on lab safety. Some representatives keep a reusable lab coat with them, and wear it from lab to lab, washing it at home when visibly dirty. There are some OSHA violations in those behaviors. PPE that is used on a lab cannot be removed from that lab (except for professional laundering). Lab coats used in a laboratory cannot be laundered at home. These are unsafe (and illegal) practices, but until someone notifies the representatives about them, the behaviors will continue.
When someone works in the lab “badlands” every day, it is easy to become complacent about the hazards within, or they may be well-trained and no longer consciously think about the tools they use to mitigate those hazards. That is not true for someone who may enter, someone who does not have the same background, experience, and training. Laboratorians are responsible for their safety as well, and educating those visitors about the potential dangers can keep them safe so they can go into more familiar climates with their health fully intact.
–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 monkeypox virus is poorly named. The actual source of the virus is unknown, although it is possible that African rodents and non-human primates (like monkeys) might harbor the virus and infect people. Either way, the virus has entered the United States again recently and has caused new safety concerns for laboratories around the country.
As with the novel Coronavirus pandemic, the monkeypox outbreak has created new safety concerns among laboratorians. How easily can this be transmitted? How should samples be handled or packaged for transport? Will this create a critical lab staffing shortage? How should waste be treated? It is vital that lab leaders and safety professionals answer these questions for staff and relay as much information as possible to allay unnecessary fears.
First, one of the most important areas of focus for laboratorians potentially working with monkeypox patient samples is to continue to utilize Standard Precautions. As always, all specimens in the lab setting need to be treated as if infectious. When handling standard clinical specimens (blood, body fluids, etc.) from suspected monkeypox patients, no extra safety precautions or PPE should be necessary in the lab. The quantity of pox virus likely to be in clinical specimens is low, although procedures that generate aerosols should always be avoided.
Laboratory staff should also be trained to package and ship Category B specimens. The current West African strain (clade) of monkeypox in the U.S. is not considered Category A under the Hazardous Materials Regulations (HMR), so monkeypox swab specimens for virus testing should be shipped similarly to other clinical specimens. Use the packaging kit and follow the instructions from the receiving testing lab.
There may be concerns about the spread of monkeypox infection among employees in the laboratory. Any infected employee should be using PPE when working in the department, and the monkeypox virus is only spread by close physical contact, direct contact with the infectious rash, scabs, or body fluids, and touching items (such as clothing or linens) that previously touched the infectious rash or body fluids. If there was contact with infected PPE or if an employee had prolonged face-to-face contact with an infected co-worker, that should be reported. The CDC states that monkeypox can spread from the time symptoms start until the rash has fully healed and a fresh layer of skin has formed. The illness typically lasts 2-4 weeks. People who do not have monkeypox symptoms cannot spread the virus to others. Direct any concerns to the employee health practitioners.
Laboratories should have an emergency management plan in place which includes how to handle staffing shortages. That plan may include sending routine testing to an alternate location, using point-of-care testing or reducing services to a limited test menu. In most laboratories, however, this monkeypox outbreak is unlikely to create a massive staffing outage. The virus does not spread quickly or in public, and a pandemic of monkeypox is not expected.
Handling monkeypox waste is another consideration for laboratories. Normally, the waste associated with monkeypox virus is considered a Category A waste (waste contaminated with a known highly infectious substance). However, waste from patients infected with the current West African strain of monkeypox is considered exempt from the category A Infectious Substance Regulations according to the Department of Transportation. It can be managed as regulated medical waste. Soiled laundry, including lab coats, should never be shaken or handled in manner that may disperse infectious particles. Laundry should be contained (bagged) at the point of use. Organizations should contact their local public health authority for more information if needed. As the past few years have shown, new threats will continue to emerge, and they will raise safety questions in the laboratory. As always, laboratorians should stay vigilant, pay attention to the work they do every day to avoid injuries and exposures when handling any specimens. Communicate with the hospital departments to ensure proper internal specimen transport of clinical and diagnostic (swab) specimens. Handling laboratory specimens has never been monkey business- the use of Standard Precautions and safe work practices will keep employees safe through this outbreak, and for whatever comes next.
–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.
In June of 2017 just at the start of the annual American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois, there were at least 7 new FDA approvals for immuno-oncology agents targeting PD-L1 in cancer. At that time (2017), there were 2030 potential agents targeting 265 different targets across cancer including the modalities of t-cell targeted and other immunomodulators, cell therapy, cancer vaccines, oncolytic viruses, and CD3-targeted bispecific antibodies. Just three years later (2020), prior to the COVID-19 pandemic, this landscape had increased to 4720 potential agents targeting 504 targets across the same spectrum. That represents a 233% growth in these agents. Although only a fraction of these is “approved” (i.e., FDA approved and in use in patients clinically), many these agents are in clinical trials that require patient recruitment using pathology and other testing data. What does this mean for pathologists and laboratory professionals? Depending on the tumor being targeted and the target, there may or may not be a specific laboratory test that needs to be performed which may be routine, like histology parameters or immunohistochemistry, or may require advanced methods, like unique antibodies/clones, specific quantification methods, or molecular testing. The range of testing is not even unique to a specific therapy—for example, pembrolizumab uses staining for PD-L1, MSI, or no testing at all depending on tumor type. For the sub-specialized pathologist that focuses on one or two organs only, mastering the rapid pace and required diagnostic-therapeutic pairings is still a challenge. Imagine what it is like to be a general surgical pathologist in a community setting serving a community cancer center. Moreover, the diagnosis of a specific tumor is often completely disconnected for any biomarkers that may be indicated at the time of collection or several months later depending on therapeutic outcomes. This poses a range of problems in logistics and processing that are still being worked out at the individual system level. Still, the plethora of new treatments for cancer patients is very exciting.
In 2017, the largest group of targets (which was heterogenous) were tumor associated antigens (TAA) which are molecules that are not normally found in the human body produced by tumor cells as the result of changes to cellular processes. Whether it is hybrid proteins, glycosylation, or phosphorylation products, etc., these unique antigens held amazing promise as something we could target and destroy without fear of hurting normal human cells. However, the bulk of these approaches were for tumor vaccines (>90%) in 2017, dropping to 58% in 2020 (and from a total of 265 to only 198). To date, however, only a handful of cancer vaccines have been fully approved including sipuluecel-T for metastatic prostate and T-VEC for advance melanoma. This example category creates a complex set of challenges for pathologists and laboratory professionals. What data is needed about a patient or their tumor before a vaccine can be used? Does it require special studies that are not easily available or are costly? After vaccination, what follow-up tissue or blood studies are needed to follow the patient? Who dictates which tests are required before treatment: industry or medicine? But the more important challenge is: When do we, as the laboratory, pull the trigger to develop and disseminate such information and on-board new tests? Certainly, we are not going to look at Phase I trials and start taking about needs for future diagnostics. But by Phase III (where there is still a high dropout rate before full FDA approval) the number of potential agents and tests may still be daunting. If we wait until approval, now we are behind because our clinical colleagues will start immediately wanting to use the therapy. Tumor vaccines are an interesting category because we assume, for the most part, that there is likely only a diagnostic role needed. But then consider targets like CD-19, PD-L1, PD-1, CD3, Her2, CTLA-4, CD20, MUC1, CD22 and so on which are very familiar to our laboratory family because we often have already a test for these markers.
But is it the correct clone?
Do we have to score or interpret it differently?
When the agent is for cell therapy (the largest growth area of therapy development with 294% growth alone), what role does the transfusion medicine team play in administering or monitoring the patient?
As with the prior example, at what point do we, as a specialty of diagnosticians, dig into the forthcoming clinical trial results to plan? If our colleagues are in academic centers and are part of the clinical trials, they often are aware of and are administering the very tests that determine trial entrance. But if one reads just a few clinical trials of these agents, you may find that the inclusion criteria require a large battery of tests; however, on the other end when it is clinical ready for prime time, only one biomarker may be needed. Such a clustered landscape of information poses frustrating challenges for the clinical team and laboratory team in trying to find the way forward to get patients the life-saving therapies that are quickly arriving.
There is no question that the collision of targeted therapeutics and evolving diagnostics (i.e., precision cancer medicine) has demonstrated phenomenal growth with ever increasing benefits for patients. Affordability and access to these therapeutics aside*, studies continue to be completed and published including combinations therapies and hybrid therapies which show incredible promise. At ASCO 2022, the results of the DESTINY-Breast04 Phase III trial showed that trastuzumab deruxtecan (HER2-directed antibody and topoisomerase inhibitor conjugate) show a 49% reduction in the risk of disease progression or death versus physician’s choice of chemotherapy for patients with HER2-low metastatic breast cancer. That finding should be read a few times to make sure that the impact of this statement is very clear for pathologists and the laboratory. Previously, how we report HER2 (0, 1+, 2+, 3+) was complicated and often required FISH for questionable cases to look directly for HER2 amplification. This new category of patients requires reporting accurately 1+ or 2+ (FISH negative) disease, as it has incredible implications for patients. This news follows the recent new indications for CDK inhibitors in breast cancer related to Ki-67 mitotic score. Just when we thought breast cancer was straightforward, there is more to know and, more importantly, more time and tedium and standardization needed to report it for each patient. And, of course, early triple-negative breast cancer can also be treated with checkpoint inhibitors after PD-L1 testing is performed…but that’s literally old news as the data was release in 2020 at the start of the pandemic.
Outside of therapeutics, diagnostics are evolving quite rapidly with the COVID-19-induced ability to use digital pathology more readily creating a super-highway for artificial intelligence products to be validated for clinical use. PaigeAI has two such products (one for prostate and the second for breast lymph node evaluation released March of 2022) and many others are sure to follow. In parallel, screening, imaging, and surgery have also had advancements that continue to improve patient care and outcomes. So, it seems that everything feels new in cancer but is that the case?
The bulk of tumors diagnosed in the US (and elsewhere) are done with simply H&E staining (up to 75%) with another 20% being further confirmed by a few IHC tests (bringing the total up to 95%). This is not new and, most importantly, is the standard of care for the time being that we use to classify tumors. That classification has dictated, to some degree, the correct NCCN or other cancer protocol that oncologists used to treat patients. At some point, however, sufficient data on the bulk of all tumor types will likely point precision medicine treatments at all cancers. At that point, will a tissue biopsy be necessary with full histology or will a fine needle aspiration with molecular testing dictate the care? The credible assumption is that standard histology and IHC will remain in practice for the foreseeable future because so much billing, accreditation, and compliance is tied closely to them. But we CAN envision a “histology-free” oncopathology approach that matches patients to treatments with a panel of biomarkers. Sounds amazing but also stressful from the point of view of your typical anatomic pathologist.
*But the final thought on this, and perhaps the most important, is cost. Much like the domestic energy market is facing a dwindling pool of customers who agree to pay more and more for “traditional power” while their neighbors pump excessive kilowatts into the grid with their solar panels and windmills enjoying essentially “free power”, progress in cancer screening, detection, and treatment should be dwindling the pool of potential patients and increasing the costs to deliver care to the remainder. However, data and trends suggest that cancer is increasing globally. Why, if we are spending so much money and development on cancer care? Poverty and access. Cancer care is both expensive (in the US) and relatively expensive (in LMICs) with a focus on a small group of patients (0.55% of a population per year develop cancer). Projections of populations who need certain therapeutics are calculated using payer pools and markets that are existing and reliable. That does not include the bulk of LMICs. So, when we consider the cost of the PD-L1 checkpoint inhibitor class per year per patient is upwards of $125,000 USD, how can we even consider that an option for impoverished patients living off $1 USD per day? But if we don’t sort that out and treat these patients, we are assuming that persons who are impoverished are less valuable than persons who can afford expensive care. That evil logic, however, doesn’t hold true because even individuals in the US often become destitute or lose the bulk of their fiscal well-being when they must pay for cancer care—a situation that simply does not occur in countries with socialized medicine and/or universal healthcare.
Cancer care is rapidly evolving and the new tools and therapies available are incredible and miraculous for many patient types who would have faced a death sentence even 10 years ago. But with this amazing progress, we cannot ethically let people with limited resources succumb to these diseases over something so trivial as money. To do so poses harm and sets us up for failure as a species. It is for these reasons that ASCP engages in global health outreach. We are excited to have recently launched the Access To Oncology Medicines (ATOM) program with UICC and more than 2 dozen partners which will rapidly bring high-quality generic cancer therapeutics to low- and middle-income countries. In parallel with the St. Jude/WHO efforts on pediatric cancer globally, we will deliver quality cancer diagnosis and treatment to all patients everywhere.
Special thanks this month the Kellie Beumer (instructional design) and Melissa Kelly (monitoring and evaluation) from the ASCP medical education grants team for their thoughtful inputs into this piece.
-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.
Ergonomics is a safety topic that gets little respect in the laboratory, but it can become very important over time. The effects of poor ergonomics are cumulative, and they can appear suddenly. When they arise, the pain and treatment are often difficult, and as people age, healing is slower as well. Because the consequences of repetitive motion injuries are slow to appear, it can be a challenge to raise concerns and create solutions regarding ergonomics. Education and action today can prevent a great deal of future injuries and staff shortages.
There are several areas in the lab where a focus on ergonomics can create benefits, and creating healthy movement and comfort does not need to be expensive or difficult. Laboratory workstations have a primary and secondary work zone. Keep the most frequently used objects in the primary zone (within 18 inches of reach) and less frequently used in the secondary zone (within three feet). Every employee is a different size. Teach staff to take a minute before beginning work to adjust the chair and other work items to make the workstation more comfortable. Eliminate clutter beneath the workstation to allows room to stand or sit allowing for foot and leg comfort.
Chairs should have 4-way and preferably 6-way adjustability and come in a variety of sizes to fit the employees who work in the lab. Chairs should have five legs with casters that are appropriate for the surface being used (e.g.: hard casters on carpet and soft casters on tile). The backrest should flex between 90 and 113 degrees with arm rests removed on chairs in the technical area to allow the chair to get closer to the benchtop.
The tops of computer monitors should be at eye level. Since many employees may use the same monitor, having it on a movable arm will help each user move the monitor to an acceptable level. Any glare on the monitor screen can be reduced with a glare screen or by reducing the light in the department. Keyboards should lay flat to allow the hands and wrist to work in a neutral position and the arms to work at a 90 degree level for comfort.
When using a centrifuge, stand directly in front and work over the top when loading and unloading, and use two hands to close the lid. Centrifuges should be placed low enough so that employees can see into the body of the machine easily. Place antifatigue mats in front of laboratory equipment that requires standing for long periods of time. These mats relieve lower back and leg discomfort. When bending and lifting, employees should lift using their thighs and not the back. Teach staff to hold objects close to the body when lifting. Never lift more than 50 pounds without assistance from other employees or an assistive device such as a hand truck.
Capping and uncapping tubes for an extended period, phlebotomy, and transcription are laboratory tasks that require the use of the same muscle groups in the hands. When working in these areas, it is important to vary the tasks every 2-3 hours per day and take mini-breaks to stretch fingers and arms in order to prevent carpal tunnel issues.
Breaks are an important part of overall ergonomic health. It is better to take a five minute break every hour than to take a 15 minute break every four hours. It is especially important if you are using a microscope or a computer for an extended period of time. Remember the 20-20-20 rule: Every 20 minutes look up to focus on something 20 feet away and blink your eyes 20 times. This will allow you to moisturize your eyes and give them a short rest. This can help to prevent ergonomics issues such as Computer Vision Syndrome which can result in neck pain, vision problems, and headaches.
Ergonomics safety is important on all areas of the laboratory, and the best way to ensure good work practices is to perform an ergonomics assessment. An ergonomic assessment should include identifying physical work activities or conditions of the job that are associated with work-related musculoskeletal disorders (MSDs) and how to eliminate these hazards. For additional information, review the Occupational Safety and Health (OSHA) laboratory ergonomics fact sheet (https://www.osha.gov/sites/default/files/publications/OSHAfactsheet-laboratory-safety-ergonomics.pdf).
Over one third of all U.S. worker injuries are related to MSDs caused by poor ergonomics. Laboratory employees are valuable resources, now more than ever, and preventing time away from work, surgeries and medical bills for laboratorians should be a priority. The results of poor ergonomic practices in the lab do not show up today, but they will have effects tomorrow if we don’t pay attention to them. Those effects can be career-altering, career-ending, and they can interfere with the happy and healthy retirement that we all want to enjoy. Take steps today to prevent that future- provide training, raise awareness, and perform ergonomics assessments to make sure staff remains comfortable and healthy for all of their tomorrows.
–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 lab technologist approached the Lab Safety Officer to ask what should be done with a collection of liquid wastes that were collected from the chemistry analyzers. The LSO had worked with multiple labs for years helping to determine how to dispose of their liquid chemical wastes according to the regulations. He thought he was pretty well aware of the hazardous chemical wastes coming from the labs, but he had no idea this chemistry analyzer waste existed. He dug a bit deeper. As he called around to the different labs in the system, he learned not all sites were handling the waste the same way. Some sites saved the excess waste and poured it into other containers to use on the analyzers. Some labs threw the containers in the trash with liquid inside, and other sites simply poured the excess chemicals down the sink drain.
Some laboratories and lab systems are very large, and there are probably many practices, some newer, some older, that have developed over time, because “someone said so,” or because a vendor said it was acceptable. The LSO may not always be able to know about every practice in each lab. Staff should always escalate questions about waste processes when there is a concern.
Managing hazardous (chemical) wastes is a complicated process, and training and education is needed in all laboratories. The regulations surrounding waste are numerous and complicated, and it would be unlikely that every lab employee would aware of all of them. Here are some basics that are true for all laboratories:
Pouring Bulk Wastes Down the Drain is (Usually) Incorrect and Possibly Illegal
In general, manually pouring bulk amounts of chemical waste down the drain is not permitted by the EPA. What is a bulk waste? It is defined as 200 mL or more. That means if you have >200 mL of a reagent left over in a container, you cannot pour it down a drain for disposal. That chemical is now waste and must be properly collected, labeled, and stored until a waste contractor can pick it up.
There are, of course, exceptions to every rule. If a waste drain line is connected to a drain, for example, that is not considered “pouring,” and it is acceptable provided a lab has informed the local wastewater treatment center about what is going down the drain. Performing a gram stain in microbiology and letting the residual chemicals go down the drain is allowed also. That is considered part of the gram stain process, and it is not viewed as “pouring” chemicals down the drain. Also, the wastewater facility is aware that these chemicals are going down the drain.
Another exception exists in some laboratories that have an external “chemical pit” which is tied to certain sinks and drains in the lab. That means that all wastes poured down these drains go straight to a collection tank which neutralizes the chemicals. The tank is emptied periodically by a contracted vendor. Since there is no waste going to the local wastewater system, the local authority does not need to be contacted about what goes down the lab drains.
Hazardous Waste Must be Properly Stored
Anytime a lab collects chemical waste, it must be properly stored. There are two types of waste storage areas, Satellite Accumulation Areas (SAA) and Central Accumulation Areas (CAA). A Satellite Accumulation Area is a storage area near to where the waste is generated. The SAA must be within the line of sight of where the waste is made, it cannot be in another room or around the corner. You must store the waste where it can be seen from where it was generated. You cannot move waste from one SAA to another SAA. You can. However, move waste from a SAA to a Central Accumulation Area (like a hazardous waste shed outside, for example).
SAAs can store up to 55 gallons of waste. Waste must be stored inside of a flammable cabinet if it is flammable, and acid wastes cannot be stored next to bases. SAAs and CAAs must have a specific emergency contact poster hung nearby which indicates the location of the nearest fire extinguisher as well as an emergency contact in case of a spill or accident. CAAs must be checked weekly for proper labeling, open containers, and leaking, and these checks must be documented.
Hazardous Waste Must be Properly Labeled
Anytime a lab collects chemical waste, it must be properly labeled per EPA regulations. All waste containers must be labeled with the identity of the contents and the words “Hazardous Waste.” There must also be an indication of the waste hazard(s), such as a pictogram or an NFPA diamond. If waste is collected into an empty reagent jug, you may not use the wording or warning label from the original jug.
Dates should never be placed on chemical waste labels when stored in a Satellite Accumulation Area, but dates always need to be on containers once moved to the Central Accumulation Area. If the waste vendor picks up containers directly from your SAA, you never need to place dates on the containers.
Again, the proper management of the laboratory hazardous wastes is complicated. There is a great deal to learn and to put in practice. Many regulations have exceptions, and some of them depend on the facility’s waste generator status. If you have questions, reach out to your EPA (or state branch) representative, or ask an available safety expert. Make sure your lab is handling chemical wastes appropriately and safely.
–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.
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