management/administration – Page 16

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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-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.

Waste Not, Want Not

In the year 1987 medical waste became a national issue when syringes, needles and other medical wastes began to wash up on the shores of New Jersey. There were multiple episodes that both posed danger to the general public and revealed a potential healthcare-created environmental disaster. It was obvious that many hospitals and laboratories were not properly handling and disposing of their wastes. In the ensuing years, many laws and regulations were put into place that affect how labs and hospitals should handle their many different types of wastes. How is waste segregated in your areas? Do you separate regular waste from biohazard trash? Do you store chemical wastes in a room or department away from the lab? Some of these practices are not safe, and others may harm the environment and break the law.

There are multiple waste streams generated in the lab. Staff should be aware of each, and they should handle each differently. While a few waste streams may be combined legally, it is important not to do so in order to reduce department expenses and in order to protect the environment. Regular (non-hazardous) waste includes paper items, specimen transport bags, and gauze pads used for disinfection. In many areas of the country, items that are not visibly dripping with blood or body fluids (saturated) can be placed into regular waste containers. These items might include disposable lab coats, plastic transfer pipettes, and gloves. Knowledge of proper disposal here is key- fines can be levied against the hospital or lab for disposing of bloody items into the local landfills. Also, in many states, any item with a biohazard symbol may not be disposed of into the regular waste stream, even if the item is clean. Be careful about tossing away biohazard-labeled specimen transport bags.

Another common lab waste includes Regulated Medical Waste (RMW) which encompasses biohazard waste and biohazard sharps. RMW should be placed into containers that are closable and constructed to contain all contents and to prevent fluids from leaking during handling, storage, transport, or shipping. If the lab is responsible for changing its own biohazard waste bags, they should be tied in such a way that the bags will not leak (i.e. the use of a gooseneck knot rather than a square knot). Then the bags need to be placed into a container with a tight-fitting lid for removal from the department. It is not a requirement that RMW trash containers in use in the lab have a lid (unless it is a sharps container). RMW removal is expensive, and it is typically charged by weight. Sharps container disposal is also charged by weight and is much more expensive than bag disposal since these containers are usually incinerated.

This is why trash segregation in the lab is critical, and teaching it to staff is not difficult. Some biohazard waste ends up in biohazard landfills. These landfills are more expensive to create and to maintain, and the potential for environmental contamination is greater than from standard municipal landfills. If environmental concerns aren’t a motivator on the lab, then cost may be. Throwing items into biohazard trash bags and sharps containers that do not belong there creates unnecessary spending. That money would be better utilized for product purchases, equipment, and salaries. Many labs decide it is easier to provide only biohazard trash containers and no waste education. That is not a good practice.

A third lab waste is Hazardous or Chemical waste. Often hazardous waste is removed from the lab via a contracted waste handler which may charge the lab by chemical weight, number of barrels, or even time spent in waste collection. Final disposal of the chemical waste usually occurs via incineration, fuel blending, or even burial. Once hazardous waste is generated in the lab, the labeling, storage and tracking of it become vital processes that must be properly managed. A Satellite Accumulation Area (SAA) is a place in the lab where chemical waste may be temporarily stored before it is moved to a Central Accumulation Area or until it is picked up for final disposal. The SAA should be within view of the point of generation of the waste- you should not move the waste to another area unless that area is a CAA. A Central Accumulation Area (CAA) is where hazardous waste is stored until it is picked up for final disposal at an outside facility. These regulations about chemical waste may vary by facility depending on the facility’s EPA waste designation- bit that’s a topic for another time. If you aren’t aware of that designation, speak to your facility director to find out.

Some laboratories generate other types of waste that may need consideration. Radioactive waste, universal waste (batteries, light bulbs), and mixed wastes (hazardous and radioactive) all need to be managed and require proper disposal. Labs should also look at waste reduction methods such as solid and liquid recycling and replacement of hazardous chemicals.

Performing waste audits is the final step in the waste program management. Reviewing regulations, physically inspecting lab waste streams, and reviewing waste records will help you understand what your lab needs are. If you need help with training, contact your waste vendors, they may have the education materials you need. Management of the laboratory waste program is important, and it accomplishes multiple goals – money savings, regulatory compliance, and the safety of your staff.

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In Regards to Laboratory Medicine, Is Nursing a “Biological Science?”

The Centers for Medicare & Medicaid Services (CMS) think so.

Recently, the American Society for Clinical Pathology (ASCP) alerted its members to this action. From the email:

“On April 1, CMS announced that “an associate’s or bachelor’s degree in nursing is equivalent to an associate’s or bachelor’s degree, respectively, in biological science”—seemingly declaring that individuals with a nursing degree are potentially as qualified to perform advanced testing as certified laboratory professionals. It also appears that CMS’s position could allow individuals with as little as a bachelor’s degree in nursing to direct a CLIA moderate complexity laboratory and/or serve in senior supervisory roles within a CLIA high complexity laboratory. Since the Clinical Laboratory Improvement Amendments (CLIA) of 1988 doesn’t specifically require clinical training of individuals with a degree in biological sciences, CMS’s new policy exempts individuals with a bachelor’s degree in nursing from any specific training requirement prior to performing high complexity testing for diagnostic purposes.”

ASCP is urging the laboratory community to ask CMS to reconsider its position that nursing is a biological science for purposes of performing laboratory testing by signing this petition.

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.

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.

New Assay to Detect CRE Available

From the press release:

“The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics.”

Read the Cepheid release here.

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.

Safety in Your Surroundings- the Physical Environment

Over the years, many safety standards and guidelines have been published regarding the Physical Environment of the laboratory (or the Environment of Care). The laboratory environment is not inherently a safe space, so training lab staff about their physical environment is critical so that they may work there without harm. The Physical Environment (PE) includes the overall laboratory space, electrical safety, and compressed gas safety. Physical Environment safety is concerned with ensuring that the facility is constructed, arranged, and maintained to ensure staff and patient safety.

Many labs I have visited are old, and space is often at a premium. Technology has changed over the years in the field of lab medicine, and that has led to the need for different floor plans, counter arrangements, and even work flow patterns. In any lab, the space should be arranged so that the quality of work performed, the safety of the staff, and any patient care given are not compromised. That means there should be enough space to perform the testing required in the department. There should also be room (offices or counter space) for those who perform the administrative work it takes to keep a lab running. Other facilities needs should be available as well such as storage space, rest rooms, staff lockers, a break room, and even meeting space.

One aspect of PE that needs scrutiny is the actual environment (temperature and humidity) of the lab space. The room temperature and humidity need monitoring and controls in order to properly store items in the space, and to ensure that testing is performed in the proper environment determined by the test manufacturer. Working outside of those parameters can have a direct negative impact on patient care. The other important consideration for the environment is staff comfort. Many building systems struggle with maintaining the proper temperature and humidity, especially in the extremes of hot and cold weather months. Will the lab staff remove PPE because it’s too hot? Of course that is an unsafe practice, and finding ways to manage the environment for staff comfort is critical.

Electrical safety should also be considered when evaluating the laboratory Physical Environment. Make sure employees have electrical safety training, and teach them about common errors made from not properly understanding electrical safety. One common error is the use of extension cords. In most locales, extension cords may be used in the lab in an emergency situation (such as accessing emergency power outlets during a power outage), but they should never be permanently placed and used for any lab equipment. The use of “daisy chains” is another common mistake. A daisy chain is made by plugging one multi-plug adapter into another for length. This is a fire hazard and should be avoided.

Compressed gas tanks are often found in the lab environment, and staff needs to adhere to special safety considerations regarding those tanks. Make sure all tanks are secured with a chain or other stabilizing device. A tipping tank, if it breaks open, can blast off like a rocket and cause great damage or even kill. Some tanks have even been propelled through walls or floors. Always transport tanks of compressed gas on a cart, dolly, or hand truck, and ensure all tanks are clearly labeled at all times.

Other considerations in the lab physical environment include the overall neatness and cleanliness of the space. Safety for the staff is improved in a clean and orderly work area. Biohazard work area floors should be wet-mopped at least once a day. Histology and other lab areas that use paraffin in their procedures should make sure the floors are cleaned and scraped so that they are not slippery from the wax. Laboratory counter tops should be neat and orderly, and they should be disinfected after each working shift using a 10% bleach solution or bleach product.

Education and training about PE topics is clearly important, but it is also valuable to regularly monitor the lab space to ensure that safety is maintained. Perform regular (monthly or quarterly) audits on the lab physical environment using a checklist. Use a complete list that covers all of the areas discussed, and be sure review every item on the checklist each time the audit is performed. It is surprising how quickly and easily things change in the lab work space. For example, an analyzer may have been moved for repair and placed back into its original location- but what if that movement caused fraying in the electrical cord? Now there is a fire hazard that didn’t exist just days before, and it needs to be rectified quickly. Sometimes we take for granted the spaces in which we work, but in the laboratory it is important to remember that PE safety needs attention, maintenance, and regular checks. Performing these functions can transform an inherently dangerous space into one in which patient results can be obtained safely.

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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.”