management/administration – Page 15

Utilization Management – Where Have We Been and Where Are We Now?

Healthcare organizations are under increasing pressure to increase value. It is well known that a significant portion of laboratory testing is unnecessary. As a result, many organizations have started laboratory utilization management programs (LUMP) to reduce the waste associated with laboratory orders. Each month, I’ll address a series of topics related utilization management.

Conceptually, LUM is not difficult. It is much like any other improvement process such as Deming’s PDSA cycle (Plan Do Study Act) or the DMAIC (define, measure, analyze, improve, and control) cycle used by Six-Sigma. In the context of LUM, one must identify opportunities for improvement, design and implement an intervention, and study the results. Most organizations are familiar with these approaches and utilization management is nothing more than directing these improvement methodologies to laboratory testing.

The success of a LUMP depends on the proper organization of the program. Top management support is very important. At my hospital, the LUMP was driven by an initiative called Value Driven Outcomes which was started by the Dean of the Medical School, Vivian Lee.(1) This program affected all parts of the organization – including the lab. We formed a LUM committee that was chaired by the Chair of Internal Medicine and included high-level representatives from Information Technology, Pathology, Finance, and education. The high-level support made it possible to overcome resistance and move quickly. I speak to many clinicians and managers across the country who are involved in LUM. Almost invariably, those who have top-level support are more satisfied with their progress. In contrast, those who approach LUM from the bottom up are less satisfied. They make progress, but the path is more difficult.

Identifying opportunities for improvement is the most challenging part of UM Opportunities are usually identified by comparing performance against a guideline. Unfortunately, the number of tests (~2500) far outnumbers the availability of guidelines (~200).

Benchmarking is alternate approach that can be applied to almost any test. In benchmarking, one compares testing patterns across a number of organizations and looks for outliers(2). The presumption, which is not necessarily true, is that unusual order patterns are associated with unusual order patterns and that tests with unusual order patterns are most likely high-yield targets.

There are several good sources of guidelines. The Choosing Wisely campaign provides a good list of tests that are obsolete. A forthcoming CLSI document on utilization has a chapter that provides a long list of targets. Repeat testing is also a common target and several recent guidelines have been published on testing intervals. (3-5)

Although there remains much to be discovered with respect to guidelines, interventions are fairly static. I haven’t seen much new since the 1990’s. A recent review categorized interventions as education, audit and feedback, system-based, or penalty/reward.(6) All of these seem to work, but there is a lot of variation across studies – even within one intervention. A forthcoming CDC study will add to this literature.

Overall, the bottleneck in LUMPs are finding guidelines and doing the analysis to determine whether an opportunity exists. National organizations such as CLSI do a great service by compiling this information.

That is the overview. Next time, I’ll pick a more specific topic.

Kawamoto K, Martin CJ, Williams K, et al. Value Driven Outcomes (VDO): a pragmatic, modular, and extensible software framework for understanding and improving health care costs and outcomes. Journal of the American Medical Informatics Association 2014:amiajnl-2013-002511.

Signorelli H, Straseski JA, Genzen JR, et al. Benchmarking to Identify Practice Variation in Test Ordering: A Potential Tool for Utilization Management. Laboratory medicine 2015;46:356-64.

Janssens PMW, Wasser G. Managing laboratory test ordering through test frequency filtering. Clinical Chemistry and Laboratory Medicine 2013;51:1207-15.

Orth M, Aufenanger J, Hoffmann G, et al. Recommendations for the frequency of ordering laboratory testing. LaboratoriumsMedizin 2015;38.

Lang T. National Minimum Re‐testing Interval Project: A final report detailing consensus recommendations for minimum re‐testing intervals for use in Clinical Biochemistry. https://www.rcpath.org/asset/BBCD0EB4-E250-4A09-80EC5E7139AB4FB8/. 3013. Accessed: May 30 2017.

Kobewka DM, Ronksley PE, McKay JA, Forster AJ, Van Walraven C. Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: A systematic review. Clinical Chemistry and Laboratory Medicine 2015;53:157-83.

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-Robert Schmidt, MD, PhD, MBA, MS is a clinical pathologist who specializes in the economic evaluation of medical tests. He is currently an Associate Professor at the University of Utah where he is Medical Director of the clinical laboratory at the Huntsman Cancer Institute and Director of the Center for Effective Medical Testing at ARUP Laboratories.

Safety Success in the Anatomic Pathology Laboratory

The pathologist walked into the histology laboratory every morning to say hello to the staff. As he did so, he drank from his cup of coffee.

The gross room was very small, and the eyewash station was placed on the faucet in the only sink in the room. One foot above the sink were the sharp ends of all of the cutting tools that hung on the wall. That was also the hand washing sink.

The morgue was the only space in the hospital where chemical waste could be stored before being picked up. The waste containers were not dated, and a funnel was left in the opening of one of them.

It can be difficult to oversee safety for a clinical laboratory, but often the people responsible for it have a clinical lab background, so the understanding of the regulations is clear. However, if you are responsible for the anatomic pathology (AP) areas as well, you may need to broaden the scope of your safety learning. Each of the lab safety situations mentioned above are real, and detecting and resolving those and other issues is important. Knowing the regulations for histology, cytology, and the morgue settings is a good place to start. Next, spend some time in those areas, and learn the processes that occur every day. Ask questions and look at procedures.

Bio-safety regulations in the AP lab are no different than for clinical laboratory staff. Many specimens, body parts and cadavers may be handled, and Standard Precautions should be used. That includes the use of gloves, lab coats, and face protection.

Chemical hygiene is also important in the AP lab, and since these areas tend to utilize many more chemicals than others, the management of them can seem daunting. Be sure to keep an updated chemical inventory which designates carcinogens, reproductive toxins and acute toxins. Ensure all staff have access to Safety Data Sheets (SDS) and that they have been trained to properly store chemicals. That means strong acids and bases should be stored near the floor, and they should never be stored together. Other incompatible chemicals should be separated as well. Ensure that proper spill supplies are available, and that staff can clean up various types of chemical spills. Conducting spill drills is a great way to keep staff ready for the real event.

Exposure monitoring should occur depending on what chemicals are used in the area. Managing chemical safety also includes ensuring proper labeling of all chemical containers. Primary container should have current Globally Harmonized System (GHS) compliant labels, and secondary containers also need adequate labeling. Secondary containers may be labeled using a GHS format or NFPA and HMIS conventions may be used.

Chemical or Hazardous waste handling must also be monitored closely in AP areas. If chemical waste is stored in the lab in a Satellite Accumulation Area, the containers should not be dated, and they should be stored at or near the point of waste generation. Central Accumulation Areas are areas where waste is stored before it is removed from the site. In these areas, containers must be dated, and a log should be kept for weekly checks of the areas. Weekly checks include looking for container leaks, dates on containers, and making sure containers remain closed. All chemical waste containers must remain closed unless someone is actively working with them. Never leave an open hazardous waste container open or with a funnel in it while unattended.

Special safety consideration should be given to tissue cutting in the histology area. Microtome and cryostat use presents specific sharps dangers because of the large sharp blades in use. If a blade guard is included with the equipment, train staff to always engage it before placing hands near the blade. Use magnet-tipped implements to remove the blades and rubber-tipped forceps to install new ones. Follow manufacturer guidelines for cryostat decontamination, but avoid using formaldehyde fumes for that purpose.

If laboratory staff is exposed to formaldehyde concentrations greater than 0.1 parts per million in their routine work, there is a safety training program that is required by OSHA. This formaldehyde training needs to be administered at the time of initial job assignment and whenever a new exposure to formaldehyde is introduced into the work area. The training must also be repeated annually.

As a lab safety officer, I learned over time how to work with and coach pathologists for safety. There is no more coffee consumed in the lab. The cramped gross room was remodeled to improve safety. Understanding the issues and reporting them was the key to getting this done. It took a difficult inspection by the EPA to teach me how to properly handle chemical waste. Today the representative from the state is my best reference, and she is willing to come to the labs and help us with waste regulation compliance. If your background is clinical, don’t ignore the special considerations in the anatomic pathology areas. Use your resources to learn what happens there, and understand the regulations so that employees in every area of the lab can work safely.

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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.

Everything DiSC Workplace

As part of my work as a leadership coach and consultant, I’ve had the good fortunate to participate in several life- and work-transforming certification programs and courses. Everything DiSC Workplace stands out from the others because of its simple yet transformative power. For me personally it has given me direct insights into how I can adapt my behavior to become more effective with people who behave similar to me and with those who behave differently. Understanding the four different personality types of the Everything DiSC Workplace model allows me to get better results, be more productive as an employee, and it gives insights into my own workplace preferences. As a result of this course, I’ve learned how to tailor my approach to the situation and the people involved. Should I be more direct or soften my language? Should I focus on building rapport or present a lot of data to get my point across? Here at ASCP, Everything DiSC Workplace is one of our fundamental courses that every employee takes.

Everything DiSC Workplace focuses on people’s behavioral patterns and preferences while at work. The model distinguishes between four main styles:

D for Dominance
i for Influence
S for Steadiness
C for Conscientiousness

All styles are equally valuable and useful. In fact, all people use all four styles, but everyone has a preference of one or two styles. Typically speaking, those with a preference for the D style would describe themselves as active and questioning. Those with the i-Style are more active and accepting. The S style relates to people who are accepting but thoughtful, and those with the C Style are thoughtful and questioning.

There are behaviors, motivators, stressors, and priorities associated with each style. Understanding your own preferences and your strengths and growth opportunities is a great foundation for your leadership development.

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-Lotte Mulder earned her Master’s of Education from the Harvard Graduate School of Education in 2013, where she focused on Leadership and Group Development. She’s currently working toward a PhD in Organizational Leadership. At ASCP, Lotte designs and facilitates the ASCP Leadership Institute, an online leadership certificate program. She has also built ASCP’s first patient ambassador program, called Patient Champions, which leverages patient stories as they relate to the value of the lab.

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I thoroughly enjoyed the Everything DiSC Workplace. It was an assessment that I hadn’t done before and I found it to be very accurate in describing my behaviors and attitudes. I have gained quite a few insights about myself, the people I work with, and even the leaders that I report to.

I am a C DiSC style, the conscientious style, the one who likes to take the time to consider all the facts and make an objective decision. Great, right? Well, I don’t always remember to be personable. So, when I look over a project, I can be rather blunt. My input can come across as corrections or criticisms. This is something I need to watch out for as a C. In the past I have tried to explain that there were no bad feelings on my part; no dislike or intention to belittle. Those who were upset by my manner often continued to react in the same way. Now I have learned to never lead with a correction or change, but to stop and consider what someone has done first. If what they have done will work, even if it is not what I would have done, I thank them for taking care of it and doing such a great job. If it won’t work I still thank them first, but I may ask a few leading questions as well. Perhaps we can come up with some improvements together. I seem to have a much better rapport with my coworkers now and they seem to be more willing to add their own suggestions.

As I look around my workplace, I can see the styles that many of my coworkers prefer.

A D-style that I know gets argumentative when I dismiss her ideas without explanation, yet doesn’t allow me time for the full explanation. There have been many disagreements between us. I have learned that if I acknowledge her ideas first and then add a few bullet points, it turns out that we are often actually working towards the same goals.

If I need to sell an idea to everyone, I know an “i” that I can go to. Once she gets excited about it and starts bouncing ideas off everyone, things take off from there. It is an awesome talent. It is also one that doesn’t usually work on me. This is another situation where I have learned to appreciate her ideas first and then, considerately, discuss them in more detail. I want to encourage her spirit but not dampen it if I happen to disagree.

I see the S-styles as the backbone of my lab. As I get all wound up about sudden changes, they take it all in stride. That is my C-style again, wanting to think it through before making the change. The S’s have been through a lot of changes though, and calmly accept most of them. A little appreciation goes a long way with these guys. If they feel compelled to complain about a change, it’s time to listen.

Interestingly, I have also started paying close attention to how my leaders talk to me. I have one who talks to me about big changes, explains the situation, listens to my thoughts, and gives me time to think about it. I don’t necessarily get my way, but when I go into her office ready to fight to prevent a change, I generally come back out supporting it and eager to help. It’s a C thing. Make me feel like I’m a part of what’s happening and I’m fine.

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-Stacey Robinson, MS, MLS(ASCP)^CMSH^CM,QCYM^CM is a graduate of the Clinical Laboratory Science program at the University of Texas Health Science Center in San Antonio and holds a Masters in Science in Biotechnology from Johns Hopkins University. She currently serves as the Vice Chair of the Hematology Exam Committee for ASCP.

Leading Lab Safety

The number of medical laboratory scientists is dwindling. Baby Boomers have begun their retirement, and even before that started, there were more job openings than people to fill them. That means more opportunities in the lab world, and in some cases leadership roles are being obtained by less experienced people than in years past. Whether or not one has a long lab history, one aspect of any new leadership position that will be important to grasp is management of the lab safety program.

The first step for a new lab leader is to ensure the existence of a functional laboratory safety program. Do this by looking for specific components of the program, a laboratory safety manual, a safety committee, and lab safety indicators. If these items are in place and functioning as they should, you’re off to a good start.

The laboratory safety manual may be in paper or in an electronic format. It should be separate from the hospital or facility safety manual as there are many lab-specific safety policies and procedures that are required. Maintain document control of these safety policies, ensure they have medical director (or designee) approval, and review these policies in a timely fashion. It is important to remember that while some lab regulatory agencies (like CAP) allow bi-annual policy review, OSHA requires annual reviews. OSHA covers many safety policies in the lab such as the chemical hygiene plan, the exposure control plan and many more.

The laboratory should have a functioning safety committee, no matter the size. If the lab staff is very small, the leader may play a role in the larger hospital or facility safety committee. If the lab is larger, a committee composed of just lab staff is advised. If the hospital or lab is part of a system, the committee should include at least one member from each lab site. The safety committee should meet at least monthly. It is important not to skimp on meetings or cancel them on a regular basis. Let staff know this is a priority for the leadership in the lab. During the meetings provide education, review lab incidents, and raise safety awareness. Train committee members how to perform safety audits, how to develop “safety eyes,” and most especially how to coach each other and their peers in the department.

Another important component of a functioning lab safety program is the use of safety indicators. Much like quality indicators, this safety data can be used to help determine the overall safety culture in the department. A good example indicator includes monitoring the employee exposure and injury rate. By using the laboratory’s OSHA 300 log information, a lab can compare its reportable injury data to national benchmarks. Many safety indicators are typically reactive data (or lagging), but tracking safety meeting attendance can actually serve as a leading indicator for the lab.

Once you’ve assessed the lab’s safety program, the next step a new leader should take is to assess the overall lab safety culture. This can be performed in many ways. One part of performing the assessment is by using your “safety eyes” that was mentioned earlier. Scan the lab visually. What immediate safety issues are seen? What is on the walls of the department? What types of interactions are observed? What is the physical layout? With practice and experience, a leader may be able to do the visual portion of the culture assessment quickly.

Another safety culture indicator tool is a laboratory safety audit. The results of an audit can provide much information about safety practices in the lab such as PPE use, chemical storage, and awareness of fire safety issues. One good model safety audit that can be used is located in the appendix of CLSI’s document Safety in the Clinical Laboratory (GP17-A3). This is a very comprehensive laboratory assessment and it can tell you much about your overall safety culture. As stated before, audit results can be discussed at the lab safety committee meetings, and ideas for improvements can be considered.

Managing the overall lab safety program is a big job, and it is often only one task of many that belongs to a laboratory leader. Change occurs daily in the field of lab medicine, and new leaders are coming aboard. Whether you are new or experienced, however, utilizing these basic first steps will provide a leader with the information needed to identify the safety culture and to understand how the program is operating.

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Myers-Briggs Type Indicator

Let me be honest and straightforward: this was not my favorite model when I first learned about it. Until, that is, I went through the certification to become a trainer and I fell head over heels in love, despite it being more complicated and intricate than the other models used and discussed in the Leadership Institute. The MBTI provides a deep understanding of your personality traits, natural skills, and tendencies while highlighting skills you have learned along the way. As an added bonus, this understanding isn’t tied to any life role (work, parent, child, friend, etc.). I, for instance, have a slight preference for extraversion with a lot of introversion tendencies. However, I usually come across as highly extraverted, as I learned to act more extraverted because my sister was very shy growing up and I wanted to balance it out.

The MBTI focuses on your innate personality preference, organized into four dichotomies:

Extraversion vs. Introversion (E –I)
Sensing vs. Intuition (S – N)
Thinking vs. Feeling (T – F)
Judging vs. Perceiving (J – P)

Your preferences in each category, when combined, are your type. For example, if I had a preference for Introversion (I), Sensing (S), Feeling (F), and Perceiving (P), my type would be ISFP. This type gives me insights into how I interact with others, process information, come to conclusions, and approach the outside world. Understanding this will allow me to know my strengths and weaknesses as well as those of others. As a leader, applying that knowledge effectively in different situations and with different people is essential.

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Yin and Yang

Who would have thought that our personality is made of contradicting elements?

I truly enjoyed the MBTI course, it was an eye opener of who I am and a trip inwards. Knowing who we really are, our talents, comfort zones and blind spots will help us become better leaders.

So now I know and after all these years (on a personal or professional level) that I am an “ENFP,” these four letters mean that I tend to be extraverted, intuitive, feeling and perceiving. I do agree with the assessment as it reflects who I am and decided after taking the course to put my Middle Eastern Ego aside and not challenge the blind spots.

ENFPs see new possibilities in people, situations, tasks and projects at hand. We tend to have high energy and flexibility. In my line of work, being the Chief Quality Officer at MedLabs Consultancy Group in Amman-Jordan, I find these personal traits very critical to our success as a company to ensure the highest compliance in implementing quality standards throughout our network of laboratories spanning four countries and exceeding 50 in total. Being a people’s person is a great asset in order to touch the hearts, minds and souls of our staff to sustain these quality standards, being 150% convinced rather than simply following the rules. We are trying to “personalize” Quality and Safety, this can only be accomplished through connecting with each staff member and it requires inspiration, a trait that is “built in” ENFPs.

Looking at the blind spots, I find that we tend to get overexcited about projects, juggling many at the same time and loosing track of priorities in the hope of making a difference. Guilty as charged.

I am learning to take one project at a time, see it through completion and start the next one in the pipeline, this gave me and my colleagues a breather and time to reflect if the road that we are taking is indeed the correct one.

So now I am asking myself, what if I did not have the great opportunity to be part of the ASCP Leadership Program and I have missed out on MBTI? What if I did not realize that I am an ENFP? What if I could not appreciate the blind spots?

The simple answer is: I will be a classical leader in it for the title, with little contributions and not much of a positive effect on those who are around me. My job will be stale, with no spirit and dull, so I guess Yin and Yang actually works.

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-Nael M. Soudi holds a bachelor degree in Microbiology from State University of New York at Plattsburgh (USA). He completed both his Master Degree in Molecular Biology and a postgraduate program in Cytotechnology at Johns Hopkins University (USA). Mr. Soudi is a certified Practitioner in Health Care Quality (CPHQ) and a certified consultant and inspector with the Healthcare Accreditation Council. He is also certified by the International Academy of Cytology (IAC) and the American Society of Clinical Pathologists (ASCP) – Cytology. Mr. Soudi is fully licensed by the American Society of Clinical Pathologists and the College of American Pathologist (CAP) as a Certified Inspector. He is a frequent presenter at regional and international conferences discussing topics in Cytology, leadership, accreditation and healthcare quality.

Your Reaction to Safety

The toddler’s father let her hand go so he could pay for their dinner at the busy airport. The little girl quickly wandered away and suddenly found herself at the top of a long escalator that was going down. No one was watching.

Mrs. Anders was walking home as she did every day from the neighborhood pool. She was very hard of hearing, but she was as friendly as she could be. As she waved to you while crossing the street, you see the car speeding toward her at too fast a pace.

You may have encountered a situation similar to one of these, or you may have seen something like it in a suspenseful movie or television program. The scenario is something that can create a reaction in you, a feeling of sudden dread, and the urge to take quick action. That’s a good response, and it could save someone from a serious incident.

But is your reaction the same in the lab where you work?

Lisa processed some CSF samples at the front desk that were delivered from another lab. She later received a call from the sending lab alerting her that the patient was positive for CJD, a prion disease, and the specimens were sent in error. When she went to clean up the processing area and tell the other staff, Lisa saw her co-worker leaning on the counter and using the computer with no PPE.

In the morning, Ken dropped a glass bottle of hydrochloric acid on the lab floor, and it shattered and spilled. He went to get the spill clean-up kit, but before he returned, the pathologist walked into the department wearing open-toed shoes.

Now let’s try something a bit subtler:

Robert is working in the chemistry department and he uncaps the next batch of tubes to be analyzed behind the safety shield on the counter. He places the tubes in the rack and carries the rack over to the analyzer. He’s not wearing any face protection.

Sheila was the supervisor in hematology, and she was walking through the department as Dwayne was on the phone with a service representative about the broken analyzer. The rep asked to speak to Sheila. Dwayne hands her the phone with his gloved hands, Sheila is wearing no PPE.

As a lab safety professional, one of my goals is to help lab staff have that same urgent gut reaction- that feeling that something is wrong and needs immediate correction- in all of those lab scenarios above, particularly the subtle ones. In each of those moments, the risk of danger or infection is very high and needs to be mitigated. All too often, however, these events occur in labs and no one reacts. That’s a safety culture problem.

There are many possible reasons for that typical lack of response. People are busy, the unsafe practices are common, or safety is simply not a priority. Lab injuries and exposures continue to occur across the nation, so the issues need to be addressed, and there are ways to do that successfully.

One method I use in safety training (that I’ve written about before) is the development of “Safety Eyes.” I call that the latent super-power that everyone possesses, but it needs to be taught and honed. When you work in a particular environment every day, it can become difficult to see the safety problems without training and practice. Take pictures of unsafe lab practices or problems and show them to staff. Have them identify the issue. As they practice, they will begin to see issues more often. Take practice safety walks with staff and look for issues. These actions will help everyone’s “Safety Eyes” to develop and become powerful tools in the department.

Of course, just seeing the issue is not enough. The second important piece here is teaching staff to respond when they do spot a problem. That can take some training and empowerment that may be new ideas for many. Teach staff to coach their peers for safety. This behavior will show others that safety is a priority, and over time more and more staff will begin to follow suit.

To produce the reaction you want in your laboratory—the issue is noticed, there is a sudden sense of dread or a gut reaction, and then there is a correction made—takes consistency. The lab safety leader will need to provide education about the regulations. Next, develop the “Safety Eyes” of the staff through pictures and safety walks. Finally, teach them to respond to the problems. As people, we are aware of the immediate danger when we see a toddler at the top of the stairs. The possibility of harm is clear to us. If you can produce that clarity for your staff with lab safety issues, you can get those reactions that can only improve your safety culture, and you can drastically reduce those injuries and exposures.

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Leadership is WEadership

Leadership is all about the other person; it is about adapting your own behavior and communications styles to meet the needs of the people you are leading. However, in order to be able to adapt your own behavior, you first need to learn about yourself. Discovering your natural leadership styles, communication and delegation preferences, views about conflict, and your strengths and weaknesses will improve your leadership abilities. This learning requires a deep-dive analysis through one (or preferably all) of these methods:

Self-reflection
Feedback from others
Coaching
Self-assessments

Personally I have always been drawn to constructive feedback so I can discover areas for growth. It’s not always pleasant to hear, but we all have blind spots, and feedback is a crucial first step in personal and professional development. In the last few years I have added another layer of self-discovery: self-assessments. In my experience, self-assessments give you 1) a sense that you are not alone; that your thoughts, behaviors, the ways in which you process information are not different than everyone else but that there are people who behave, think, and process in similar ways, 2) a deeper sense of understanding where your behavior or communication preferences come from, and 3) a practical understanding of people who act differently than you and how to approach them more effectively. In other words, self-assessments are a way to acknowledge one’s own behavior and that of others. So much of leadership is about acknowledging other people through adapting your own behavior.

When I got hired to create a Leadership Institute for ASCP members, I used self-assessments as the cornerstone of our curriculum. I want our members to have access to the same level of awareness and development that I have enjoyed throughout the years. Learning about your motivators and blind sides is crucial before you can truly turn leadership into WEadership.

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Phlebotomists and PPE: How Do You Decide?

When it comes to making a decision about Personal Protective Equipment (PPE) in the laboratory, OSHA is pretty clear about how to go about making the selection. The use of risk assessments and task assessments is required by OSHA’s Bloodborne Pathogens standard, and these can be essential tools in making decisions regarding safety throughout the laboratory. The decision-making tools and processes can be applied to the patient collection area as well. You might think selecting PPE for phlebotomists would be straightforward, but in some cases, it is not.

Deciding on gloves for phlebotomists is easy. The Bloodborne Pathogens standard states, “Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood … (and) when performing vascular access procedures.” (The one exception here is when collecting blood at a volunteer donor center, although gloves may be worn there as well.) So, if you have phlebotomists on your team, whether they collect blood on the patient units, at client sites, or in the lab, they all need to be wearing gloves, and it is required that they change those gloves after each patient contact. The gloves should be constructed of latex, nitryl, or another material that prevents the passage blood or body fluids (vinyl gloves should not be used).

Some of the decisions about the use of lab coats and phlebotomists are, unfortunately, more complicated. This first part of this conversation is easy. The BBP standard requires lab coats “in occupational exposure situations.” That means that if phlebotomists perform any work in the lab- if they process blood, spin it down, pour it off, etc. – they are in such an exposure situation and need a lab coat (and face protection if they handle open specimens or chemicals).

The second part is a bit more troublesome. Do phlebotomists need to wear lab coats when collecting blood from patients? According to OSHA, the answer is a clear “no.” A 2007 OSHA letter of interpretation states, “ Laboratory coats… are not typically needed as personal protective equipment (PPE) during routine venipuncture.” The letter does also go on to say that employers should perform risk assessments for any potential exposure situation in order to make decisions about lab coat use.

I do not favor the use of lab coats for phlebotomists, and I have my reasons. In my years of collecting specimens, I never obtained a splash of blood above my wrist, and I believe the risk of such a splash is minimal. As a Lab Safety Officer, I also know the use of a lab coat for phlebotomists creates several issues. If a lab coat is worn as PPE, should the same coat be worn from patient to patient? That would never happen with gloves, so if the lab coat is for protection against blood spatter, should that used and potentially contaminated protection be re-used? If a phlebotomist uses a lab coat while processing specimens in the lab, should that same lab coat be used with patients? No, OSHA says PPE used in the lab should never be worn outside the lab. Will phlebotomists change their lab coats? That is not convenient for them, and it opens the door to regulation violations and potential patient harm.

When having conversations about this topic, I have heard the argument that clothes or scrubs are worn from patient to patient if lab coats are not used. What’s the difference between that and wearing the same lab coat? The difference is that clothes and scrubs are not PPE. They are not designed to offer protection against splashes. Once you use an item as PPE, the OSHA regulations that cover the employee and how it should be viewed change.

On the other side of the coin, however, is a survey that was conducted in 2008 by DenLine Uniforms, Inc.[1] 180 phlebotomists across the country responded to questions about exposure and lab coat use. 64% of those surveyed regularly used semi-impermeable lab coats as PPE while collecting blood. 74% of respondents said they had encountered blood splashing beyond the hand area multiple times during the years they had been drawing blood. Given just this data, it seems clear that there is a high risk of blood exposure while performing venipuncture procedures, and that should mean that a lab coat should be used.

So how do you decide what to do with phlebotomists and lab coats in your lab or hospital? First, start with a risk assessment. Determine the risk of exposure above the wrist based on the collection equipment and procedures used at your location. If the risk is low, you should feel comfortable choosing not to provide lab coats for this process. If you find the risk of splash is high, implement the use of lab coats. Use caution, however, and consider the impact to patients of wearing what you consider to be contaminated PPE from patient to patient. As with all decisions about lab safety, think about the regulations, but if they don’t give you the answer you need, fall back to the choice that offers the best safe practice for your staff.

[1] https://www.denlineuniforms.com/assets/images/pdf/Blood_Draw_Exposure_Survey-October_2008.pdf

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Business and Legal Considerations for Pathology and Laboratory Service Providers

The legal considerations when providing pathology and laboratory services can be daunting. However, help is at hand! ASCP Press recently released a Business/Legal handbook. Also, in this podcast, an attorney gives listeners a basic rundown of some of the legal intricacies involved in running a laboratory.

The ABCs of BSCs

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

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

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

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

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

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

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

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

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

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

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

Scungio 1

-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.