Regulatory Inspections: Are You Ready?

Whether your laboratory is accredited by CAP, COLA, JCAHO, or simply adheres to local state and federal CLIA regulations, all laboratories are subject to regular inspections from their accrediting agencies. Normally the thought of an inspection places staff into panic or hiding mode (“Whew, glad I’ll be off that week!”), but if you prepare ahead of time, the inspection process can be an extremely valuable tool to access the overall quality of your laboratory program. Over the next 3 blog posts we’ll review tips on 1) how to prepare before your inspection, 2) what to expect during the inspection itself, and 3) how to address any deficiencies identified by the inspection team.

Part One: The Inspectors Are Coming!

Know the Regulations. As technology evolves and new laboratory methodology is introduced, the requirements for your respective regulatory agencies will be updated as well. Know what version of your checklists or standards you will be getting inspected on, and ensure all staff are familiar with any updates and changes. By engaging all staff in the inspection process from lab assistants up through management, everyone will be aware of what the requirements are and can actively participate to ensure the lab is meeting those requirements.

Focus on Previous Citations. Your inspectors will have access to your previous inspection results, and will be following up on any citations. Ensure that the corrective actions and preventive actions you said you were going to implement have actually gone into effect. For any procedural changes, have documentation (Read & Understand) ready to show that all staff were made aware of and have been trained on the changes. Make sure that those corrections have been sustained and are effective at addressing the noted citation. It’s great to add on new forms to document instrument maintenance – but not if your staff doesn’t have the time to complete them. Again, engage your staff to see what is working, and what needs to be reevaluated.

What is New? New regulatory requirements, new staffing, new instruments, new testing methodologies… These are all key areas that the inspectors will focus on. Have you kept current with your regulatory updates and implemented any necessary changes to address the new requirements? Do you have documented training and competency for each new staff member for each task they are performing? For new instruments, ensure they have been fully validated and correlated to similar instruments prior to being placed into use for patient testing. When adding on new tests, ensure you have a full validation summary with medical director approval and sign off, and that your testing activity menu has been updated as well.

Have a Plan. Depending upon the size and scope of your laboratory, there can be a lot to cover for your inspection preparations. If you wait until your inspection window opens to start getting ready, things will be overlooked or simple “quick fixes” will be implemented instead of finding a long term sustainable solution to any potential issues. Instead, schedule tasks throughout the year to continually review your quality assurance program. Ask management to review 3 – 5 SOPs each month for content (does SOP match the current manufacturer package insert, does SOP match current practice in use), rather than a mass annual sign off. Perform quarterly reviews of your maintenance documentation to ensure all logs have been filled out completely with corrective action documented when appropriate. Utilize calendar reminders to track proficiency testing sample results, and ensure proper follow-up for any non-satisfactory results.

Perform Meaningful Self-Audits. For most regulatory agencies, performing self-audits on your non-inspection years is a requirement. Make this task meaningful by using a fresh set of eyes to review your documents. Ask the hematology staff to inspect the chemistry department; chemistry to inspect urinalysis; urinalysis to inspect microbiology…. You don’t need to understand how to actually perform a specific weekly maintenance task on a particular instrument; you just need to ensure that all those weekly tasks have been documented every 7 days (or less). You don’t need to understand what reagent ‘XYZ’ is used for, you just need to ensure that the vial is properly labeled with an open and expiration date, and that it is not currently expired and still being used. Self-audits should not be punitive; they are meant to catch things that you may be taking for granted are compliant, when in fact they truly are not.

Stay tuned for part 2 coming out next month, where we’ll discuss the inspection process itself and what to expect from the inspection team.

 

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-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

Leadership Development Characteristics

Several characteristics can influence a leader’s effectiveness: self-regulation, goal orientation, self-efficacy, self-awareness, and implementation intention.

Self-regulation is one of the most essential skills a leader can have. Being able to control behavior, emotions, and cognitive processes allows leaders to adapt their behavior to specific situations and interactions. Self-regulation is similar to willpower, as both act like a muscle, meaning that leader can exercise it to make it stronger. For example, a leader can practice not to be the first one to speak even though it might be their automatic behavior. Learning how to control behavior in insignificant situations will build up the ability to control them when it is critical. Increasing a leader’s willpower and self-regulatory processes will increase a leader’s situational effectiveness as it helps a leader maintain consistency and focus to deal with challenges that arise.

A leader’s goal orientation plays a significant role in their approach to learning, which, in turn, increases leadership effectiveness. Leaders with a learning goal orientation focus on developing their competence through developing new skills. Such an orientation increases a leaders’ efforts and persistence when facing challenges, which, in turn, improves the chance of a successful outcome. Goal-orientation, therefore, indicates the current and future potential of a leader.

Internal beliefs about how well one can complete a task or handle a challenge is referred to as self-efficacy. Self-efficacy is important in leadership development because it forms the attitude towards development, which guides if a leader will participate in developmental opportunities. In other words, if a leader has a self-efficacy view that they are able to communicate effectively in all situations, this leader is unlikely to participate in opportunities to further increase their communication skills.

Self-awareness is related to self-efficacy as it revolves around the understanding of a leader’s own strengths and development areas. Self-awareness essential to leadership effectiveness because leaders need to be aware of how others respond to their communication, behavior, and leadership styles. Understanding other people’s reactions through their self-awareness, leaders can adapt their behavior to the needs of each situation and person.

Implementation intention relates both to goal orientation and self-regulation. One of the challenges of leadership is starting a task or finishing one. Implementation intention strategies can help leaders with this challenge by establishing certain behaviors that lead to goal completion. Whereas goal intention is focused on reaching a specific outcome, implementation intention revolves around performing a particular behavior when encountering a certain situation. For example, a leader’s goal intention might be to stop procrastinating on answering challenging emails, while their implementation intention might be to write a draft immediately after reading a challenging email and rereading and sending the answer an hour later. Implementation orientation guides leaders towards behavioral actions that are easy to understand and act upon. Such an orientation will guide leaders to adapt their behaviors to be more effective and will allow them to fulfill their goals proactively.

When looking at this list of leadership development characteristics, which could you further develop in order to increase your leadership potential and effectiveness?

 

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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.

The Pyramid and the Power

In 1950 the National Safety Council began describing a safety system known as the “hierarchy of controls.”  This new model was created to show that that design, elimination and engineering controls are more effective in reducing risk to workers than ‘lower level controls’ such as warnings, training, procedures and personal protective equipment (PPE). The National Institute for Occupational Safety and Health (NIOSH) began to use the hierarchy of controls, and it has been an effective safety teaching tool for that organization and others over the years. The philosophy of the hierarchy- or the pyramid- is simple: “Controlling exposures to occupational hazards is the fundamental method of protecting workers.” It is simple, and although it may not be rocket science, it’s a powerful idea.

While this hierarchy is represented differently by multiple organizations, the basic protection levels of the pyramid remain the same; Elimination, Substitution, Engineering Controls, Administrative Controls, and PPE. The most effective part of the pyramid (Elimination) is at the sharp end, or the top, and the least effective (PPE) lies at the bottom.

Unfortunately, the top two most-effective layers of the safety pyramid do not work well in the laboratory setting. We can’t eliminate or substitute the biohazards we work with- that would mean not being able to perform our work. Laboratorians handle and analyze patient samples and chemicals, and they are a necessary hazardous part of the job. There is some substitution possible in the lab when considering chemicals (the use of a non-hazardous xylene substitute, for example), but for the most part, this level of the hierarchy of controls is not very helpful to the lab.

Engineering Controls involve the use of engineered machinery or equipment which reduces or eliminates exposure to a chemical or physical hazard. Engineering Controls are definitely favored over other levels on the pyramid for controlling existing worker exposures in the workplace because they are designed to remove the hazard at the source, before it comes in contact with the worker. Well-designed engineering controls can be very effective in protecting lab employees, and they are typically independent of worker interactions so they can provide that high level of protection. Sometimes the initial price of certain engineering controls can be high, but over the longer term, operating costs are frequently lower, and the controls can ultimately provide a cost savings. Good examples of engineering controls include Biological Safety Cabinets, Chemical Fume Hoods, centrifuges, and glove boxes.

The next level of the hierarchy is represented as Administrative Controls.  These controls seek to improve workplace safety by creating safer policies and procedures in the workplace. Administrative Controls can range from the placement of warning signs throughout a lab, the provision of safety training programs, and the implementation of proper ergonomics. The part of the pyramid may be the most difficult to manage. The onus of workplace safety here begins to shift from management over to staff, and sometimes the results can be… unpredictable.

An off-shoot of Administrative Controls that is discussed often in safety models is known as Work Practice Controls. These controls are not truly part of hierarchy, but they can be important safety practices in the lab setting. OSHA describes Work Practice Controls as “procedures for safe and proper work that are used to reduce the duration, frequency or intensity of exposure to a hazard.” These are the not the actual written procedures, but the actions that put those written policies into action. Following proper hand hygiene and preventing eating or drinking in the laboratory are good examples of those actions.

PPE is at the bottom of the hierarchy of controls- by definition that means that it is the least effective method to keep employees from hazard exposure. It is the last resort for safety in the lab. That’s a powerful point, and it should be discussed when providing lab safety training. All too often lab staff carelessly perform tasks without wearing PPE, and the danger is immediate and potentially disastrous. Even though this level of protection is considered the least effective, this last barrier between the employee and the hazardous material is crucial. Lab staff are required to have PPE education, and they should be able to provide a return demonstration for the proper donning and doffing of that PPE.

The Hierarchy of Controls is typically represented as a pyramid. It’s a simple symbol, but it’s really a powerful and complex model for safety. When you look at each separate level, you can see that there is a great deal of information that can provide a lab safety professional with helpful resources. As a lab leader, you can use the model to provide education, train staff, and help to enforce good safety behaviors which will improve the lab safety culture and keep employees from harm.

 

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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.

History of Generations: Millennials

Of all the generations, it is my personal experience that this generation has received the most pushback regarding their work style, work ethics, and its influence. However, this generation is absolutely essential in today’s work environments. They bring a different perspective to work because they care about self-expression and having a purpose.

Millennials are typically born between 1981 and1999.. Their parents are Baby Boomers or Gen Xers. This is the first generation that has never known work without computer, even though not every household had (and has) one. Schools started to invest in computer labs and computer training and it started to become mandatory in the Western World to submit homework that was typed instead of handwritten. This generation was young, or sometimes not even born yet, when the internet connected the world and information became was readily and widely available. One of the characteristics of Millennials is valuing instant gratification, because they are used to having the world at their fingertips. Another is self-expression, due in large part to the widespread use of cell phones and social media.

Because of the internet and globalization, this is the most diverse generation. This is another great benefit they bring to organizations, because they create a diverse work force with people from different ethnical, educational, and socio-economic backgrounds.

This generation was told that they could achieve anything they wanted, so they are creative, optimistic, and focused. They experienced tremendous academic pressures and school shootings, which caused many students to feel unsafe in school. This led many millennials to live by the notion “You Only Live Once” (YOLO), which is also embedded in their professional lives through a focus on purpose and professional development opportunities.

 

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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.


 

When the Millennial generation is discussed, most sources agree they share these common traits:

  • live in a world of technology, have never known a world without computers, and get most information from the internet
  • Are rewarded for participation, not achievement, yet are achievement and career oriented
  • Experience enormous academic pressure
  • Want to make a difference in this world and find a career with a purpose

I was thinking about writing this post as I went to the gym for a personal training session.  As I was stretching and lifting weights, I noticed all the millennials in the fitness center!  It occurred to me that instead of relying on what researchers say are important to them, I could do my own small survey. I decided to use the KISS Principle.  In other words, “Keep It Simple Stakenas!”  I focused on one question with three parts, “What are the three most important things to you in your life as a millennial?

When I was done with my workout, I began to walk up to people who looked like they could be millennials.  Of course I made a few errors, and fortunately, they were Gen Xers and received my first question as a compliment.

Those that I interviewed who chose to elaborate all seemed to center on one shared opinion.  They sought a cause greater than themselves and a strong desire for meaningful experiences, such as learning about different cultures, people, and travel.  One stated, “I want to be the best citizen of the world that I can be.”

The first response in the first interview took me by surprise.  When asked what the most important things to her were, she said, “wifi.” The second person I interviewed immediately said, the “phone,” then finished with Family and Friends. Five of the 12 interviewed stated that their career was important and work-life balance.

As I grouped the interview answers in topics of importance, I found a common thread. I learned that 11 of the 12 people I interviewed shared what I have called “The 4 F’s,” Family, Friends, Fitness and/or Faith.

Millennials will always be there if you need a “charge!”  They understand that “wifi and cell phones” carry with them opportunities for friendships, family connections, careers, education, and even access to ways of worship regardless of your faith.

God Bless Our Millennials!

 

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-Catherine Stakenas, MA, is the Senior Director of Organizational Leadership and Development and Performance Management at ASCP. She is certified in the use and interpretation of 28 self-assessment instruments and has designed and taught masters and doctoral level students.  

Crisis Communication

It’s not every day, but most days it seems like I’m “putting out a fire”…. or two. I’m sure you know exactly what I’m talking about. Four people called in sick and now you’re extremely short staffed, your automated instrument just broke and now you have to process everything manually, you just found out that product X is contaminated and patient care could be jeopardized; the list goes on and on.

Unfortunately, not everyone is prepared for crisis. This is a problem because poor crisis management can result in harm to the organization, its stakeholders (patients, clinicians, vendors, staff, employees), or its reputation. A major threat to good crisis management is poor communication. You can prepare a great plan, but if your plan is not communicated well/properly, then your crisis could turn into a major disaster. 

The Issue

Without proper communication, operational response can break down, which can cause a significant delay in crisis resolution (1). The financial and/or reputational effect becomes more severe the longer it takes to resolve an issue. Additionally, poor communication can cause your stakeholders to react in a negative way, such as get angry, become confused, or perceive your operation/department as incompetent, or even worse- negligent.

The Solution

Anticipate the crisis. Having a plan in place can really save the day. When planning, your team should consider pre-analytical, analytical, and post-analytical risk. To some extent, analytical risk assessments should already be in place as they are required for individualized quality control plan (IQCP). The IQCP assesses specimen, test system, reagent, environmental, and testing personnel risks (2).

Identifying a communication team can help to ensure that your crisis management plan is communicated properly. The communication team should be trained on the policies and crisis management plan. Make sure that staff and leadership know who the members of the crisis communication team are, so that when a crisis does occur everyone knows who to turn to or where to look for information.

Establish a crisis notification system. Most hospitals have notification systems, but does your laboratory or department have an established notification system? Depending on the situation you will need to contact different groups of people. Having a list prepared ahead of time eliminates forgetting to communicate to a particular group or individual in the heat of the moment. Pagers, phone numbers, addresses, text messages, emails. Make sure all information is easy to access and up-to-date.

Assess the crisis situation. Ask questions. Make sure you have all the appropriate information before reacting. Our gut reaction is to act fast, which is usually a good thing, but not to the detriment of your crisis management plan. Keep calm and carry on.

Perform a post-crisis analysis. After the crisis is resolved (not too long after), it is important to review the event and determine if the process was a success. Document lessons learned; key steps to keep and areas of improvement.

The Conclusion

The laboratory is like a box of chocolates- you never know what you’re going to get….so it’s best to be prepared. Organizational response to crisis should include a good communication plan. Lastly, don’t forget to test you plan and make sure it works. 

The References

  1. https://www.bernsteincrisismanagement.com/the-10-steps-of-crisis-communications/
  2. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf

 

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-Raquel Martinez, PhD, D(ABMM), was named an ASCP 40 Under Forty TOP FIVE honoree for 2017. She is one of two System Directors of Clinical and Molecular Microbiology at Geisinger Health System in Danville, Pennsylvania. Her research interests focus on infectious disease diagnostics, specifically rapid molecular technologies for the detection of bloodstream and respiratory virus infections, and antimicrobial resistance, with the overall goal to improve patient outcomes.

Stress: When to Use It and When to Reduce It

To be honest, the word “stress” makes me feel stressed. As soon as this little six-letter words pops up in my head, my heart rate increases, my blood pressure increases, and I lose focus. Even the good type of stress, called eustress, does not sound good in my ear. It evokes thoughts of panic, of too much to do and too little time, and of shutting down.  I want to turn off all the lights and hide underneath my bed so that the stress-goblins can’t find me.

There many types of stress, including acute stress, episodic acute stress, and chronic stress. Acute stress is short, but it can be frequent. It happens for example when you make a mistake at work or when you are about to give a presentation. Acute stress is not necessarily detrimental to your well-being, but it can become harmful is you experience it a lot. Episodic acute stress is when this type of stress occurs often. It makes people irritable, short-tempered, and aggressive because they live in a constant feeling of running behind, as if they can never catch up with life. Chronic stress is when you experience stress over long periods of time. It has a significant impact on a person’s mental, emotional, and physical health and it can lead to burnout. Burnout is the physical and/or mental collapse caused by prolonged or chronic stress. It can take weeks or even months to fully recover from it, during which a person is typically not able to work. Needless to say, it is critical to avoid burnout at any cost.

Knowing how to recognize and reduce symptoms of stress has become a critical part of today’s professional life. The constant pressure to be reachable can create or increase stress, so what we really need to learn is how to create a balance between work and taking time to rejuvenate so that we are more productive during the hours we need to focus.

People develop coping resources to handle stress throughout their personal and professional lives. When you experience stress, keep track of what work best for you so that you end up with a personal coping resource list. For example, when I am stressed, exercise helps me feel better. I also know that I at times I need to check my email first thing when I wake up to get a sense of any urgent issues, and sometimes I need to delete my work email off my phone in order to cope with my stress levels. Knowing what works for YOU is the key, so trying new things and exploring different options is a great way to keep your stress levels at bay.

Work is never done. However, knowing when and how to take a break to clear and refresh your mind needs to be part of everyone’s long-term professional goal. Life and work is a marathon, so developing coping skills to handle both acute and chronic stress is essential to make sure we all make it across the finish line.

Note: Stay tuned for the upcoming release of our ASCP Leadership Institute course called Stress Analysis and Coping Resources!

 

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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.

Lab Safety for Every Member of the Team

Gretchen had been the lab secretary for six months, and she was getting comfortable in the role. From her office she scheduled meetings for the manager and paid bills, but her job took her into the lab proper at least once every day. She liked that her job allowed her to wear skirts and sandals in the hot summer months-she was glad she didn’t have to follow the dress code that was used in the lab.

Stephan was new to the lab courier team, and his training had to occur quickly since he replaced someone who filled weekend slots often. He was shown the routes to drive, but when trained in the lab area, he was only shown where to pick up and drop off specimens.

Dr. Kane had been the lab medical director for many years. One day she was talking to the histology tech and noticed the use of pictogram labels on secondary chemical containers. She had no idea what they were for, and she asked how long the lab had been using them.

Unfortunately, these scenarios are realistic, and they illustrate a problem that can create deep roots in a laboratory, and those roots can lead to a poor safety culture that will be difficult to manage. If you’re in charge of safety in the lab, it is vital to know who needs safety training, how to give that training, and when to provide it.

The who is important. Does your lab host students for clinical rotations? Do research personnel perform tasks in the department? Administrative personnel and even lab leaders who enter the department should also have safety training on record. Don’t expect pathologists to keep up with the latest safety regulations on their own either, they have many other things on their plates. Even if they are under contract and not truly employees, they should be included with certain safety training offerings. Consider biomedical engineering personnel and maintenance workers- some safety training can prevent accidents and exposures for those important team members as well. Fully train couriers and phlebotomists or anyone else who will process specimens in the lab setting. If you’re just starting to figure out safety training in your lab, make a list of all the different people who may enter the area.

Clearly all of these various people will not need the same level of lab safety training. A courier might need to know about dry ice safety, for example, but that information may mean nothing to the secretary. Be sure to customize the training for the different employees as needed. Nothing will turn people off faster than information they don’t need. If there are changes to safety regulations that require new education, be sure to involve laboratory medical staff. For example, the implementation of the Globally Harmonized System in 2016 or this year’s EPA Generator Improvement Regulations both created major changes with lab safety processes. The lab medical director is responsible for oversight of the lab, and not having knowledge about such major changes can hinder that responsibility and expose the lab to both safety and accreditation issues.

Now that you know who to train and what education is needed for each role, it is time to figure out when and how to provide that lab safety training. Some topics require annual training by OSHA and other agencies, and a computer-based module is usually acceptable. That said, other required training must include live interaction, quizzes, return demonstrations and certificates of completion. It can be a complicated task to figure out which is which, and reviewing the requirements from the source agency (OSHA, DOT, EPA, CAP, etc.) will guide you. Next, it becomes important to know your audience- those who will receive the training. What type of education will work best- a live class, computer modules, webinar, interactive round-table sessions- there may be a need for a combination of these styles.

Once you determine your safety training needs and methods, there will be more to consider in order to maintain a steady culture of safety. Conducting regular drills to ensure staff understanding should be added to your calendar. Fire drills, evacuation drills, disaster drills, and hazardous spill drills are just some that can be conducted throughout the year to ensure staff readiness. Consider giving out information on a specific safety topic each month at staff meetings. This reinforcement of the required training will benefit the entire team and the lab safety program.

It takes time and effort to create a solid laboratory safety training program. If you have to start at the beginning, learn your resources and ask for help. If you are taking over a safety program already in place, make sure the on-going training meets regulations, and create a plan to continually raise safety awareness in the laboratory for all whose job may take them into the department. That will create long-lasting value and safety for every member of the team.

 

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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.