Win, Lose, or Draw?

In the 1962 Japanese release of King Kong vs. Godzilla, it was pretty easy to determine who the winner of the epic battle was (it was Kong, if you’re keeping track). Almost 60 years later, the two famous giant behemoths met again on the big screen, this time in an American version. This second battle, while fun to watch, had a less-obvious outcome. Those who sided with either monster had moments to cheer during the movie, but in the end, (spoiler alert!) a secondary issue overshadowed the much-hyped monster match. It seemed obvious to me that the script writers tried their best to satisfy audiences on both sides of the aisle. In doing this, however, the movie lost a little bit of its punch. That can happen in lab safety as well. If the message isn’t strong or clear, safety issues will ensue.

The lab manager noticed an increase in employee injuries on the job. Someone cut their finger on a microtome blade. Two different specimen processors splashed serum into their eyes. A night shift tech kneeled onto the floor to pick up a box, and her knee landed on broken glass that hadn’t been swept up. It was clear people were not paying close attention while they were performing their duties. The manager held a meeting in the lab to raise safety awareness. He delivered his message, but staff noticed he was chewing gum and that he did not put on a lab coat even though he was in the lab for over 20 minutes. The message was not clear. He said he was for a safer lab, but he didn’t look to anyone like he meant it.

Jake was new to the histology lab and he was excited to make a good impression as he began his career. During his departmental orientation, the supervisor stressed the importance of chemical safety. Formaldehyde and xylene were in use in the department, and they were potentially dangerous. Jake got the message and was ready to show the department he could work there safely. After orientation was done, Jake came to work to begin cutting tissue. When he sat down at his station, he opened the drawer for supplies and saw a packet of oatmeal a spoon, and a coffee cup. The medical director came in to the lab to welcome Jake, and he noticed she was drinking tea. The message Jake received about safety was no longer clear. The supervisor spoke about safety, but it was clear no one enforced it.

When the message we send to staff about lab safety is mixed, we really can’t blame them when the culture is bad. The problem is that many leaders are not aware they are sending this confusing communication. If you’re not sure if you are one of those leaders, take a step back and look in the mirror. What kind of message do you send? Do you support safety? Do you do it with your words AND your actions? What sort of example do you set?

If you’re not in lab leadership, you still have a responsibility to represent safety with your lab practices as well. Everyone has an impact on the overall safety culture, not just leaders. What do you do to promote safety in your department?

Maybe you are an employee and it’s your leader who is sending mixed messages. First, make sure you’re choosing the side of safety in your work no matter what others are doing. Second, it may be time to “manage up” and ask leadership why certain unsafe practices occur. If the leader is part of the problem, it is acceptable to point that out, provided you do so with purpose, tact and professionalism.

Leading by example for safety is vitally important no matter your role in the department. Choose your side, stick to it in all circumstances, and over time you will be able to be declared the decisive winner. Those mixed safety messages usually lead to a draw, or worse, a loss for the team. 

Because I have been a Godzilla fan for decades, I thoroughly enjoyed this latest film entry. In truth, I was able to discern a clear winner of his fight with Kong despite the writer’s intentions, but that may be because I had support for my favorite going in. That might be your way to victory as well. Root for “Team Safety,” and your support will be noticed and followed for the win!

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.

Lab Inspections in a COVID World

The current pandemic has highlighted the importance of the laboratory in the delivery of healthcare. Patients and families depend on the laboratory to delivery accurate and timely results.  Regulations have been written to ensure laboratories meet society’s expectations.  Medical laboratories are one of the most highly regulated industries requiring biennial inspections by accrediting agencies. Despite operating under the COVID-19 testing pressures, laboratories still need to be inspection-ready.

New Inspection Process

As a result of social-distancing mandates and state-level restrictions, laboratories need to adjust to a new inspection environment. The College of American Pathologists (CAP) is temporarily allowing virtual inspections and has created information on its website about a few laboratories’ experiences with the virtual inspection process.

The CAP has also shared some expectations laboratories should be aware of when discussing inspection aspects.

Currently, in states where there are travel restrictions with quarantine requirements, a greater than 5% positivity rate, or where the institutions have travel/visitor restrictions, the laboratory medical director may choose to have a virtual inspection. However, the laboratory should be aware that they will still be required to have an in-person on-site inspection within 4-6 months if virtually inspected.

In addition, the laboratory director and the inspection team must both agree to perform a virtual inspection.

Virtual Aspects

Laboratories should take into consideration some of the aspects of a virtual inspection. In-person inspections for many small to medium laboratories often consist of inspectors being on-site for only one day. Conversely, virtual inspections can be weeks or even a month in duration depending on the laboratory’s size, the number of specialties, and the inspectors’ availability.

Virtual inspections also require a lot of document handling. Laboratories utilizing manual worksheets, quality control and troubleshooting logs will need to upload these documents for review. The CAP has created a secure website for this purpose, but it still requires personnel to scan each document individually.

Technical Priorities

There is also the risk of technical issues hampering the virtual process. Laboratories must have reliable Wi-Fi, electronic communication devices (laptops, tablets, cameras) and have personnel comfortable with the challenges inherent in managing multiple requests simultaneously. Having a dedicated IT person for an inspection is a great but difficult to get asset.

Mult-day Inspection

If there are no limiting COVID restrictions, laboratories may still opt for an in-person inspection.

Some inspection teams (in agreement with the laboratory medical director) have modified the in-person inspection process so that it is conducted over a 3-4 day time period. In this process, only a few inspectors come on each day to inspect specific disciplines. Usually, one inspector will return the next day to provide some continuity to the inspection process.

Instead of an intense one-day process, spreading an in-person inspection out to 3-4 days allows the team and facility to practice social distancing, reduces the level of stress, and gives the laboratory more time to provide evidence or have a deficiency changed to “corrected on-site.”

Competency Note

Laboratories need to be reminded that regardless of COVID, the requirements for competency still apply. New hires must still have semi-annual competencies performed at the required frequencies, and the laboratory must be able to provide competency documentation during an inspection.  There are no exceptions to the competency mandate.

Conclusion

It is expected laboratory administrators and managers may have a bit of angst regarding the uncertainty that comes with a new inspection process affecting the entire laboratory. Amid the COVID crises, the laboratory has been tasked to deliver high-quality results efficiently. Laboratories across the nation have met the COVID challenge and are able to adapt to the demands inspections require. Virtual inspections are just another example of the laboratory adapting to meet its regulatory and accrediting requirements.

-Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.

The Safety Sweet Spot

I have been through physical therapy for a few different issues in my life, and I must say (with apologies to the profession), I was never a believer. I had musculoskeletal issues that needed attending—a pinched nerve, neck pain, knee pain, etc. If you are past 40 years old and your body’s check engine light has blinked a few times, you know what I mean. Each time the series of physical therapy exercises seemed to be useless and a waste of time. They never really helped me. Recently, however, I subjected myself to a total knee replacement surgery. I knew PT would be a part of the recovery regimen, but I did not realize how important it was going to be for my overall recovery. Therapists taught me how to walk again, they taught me how to trust my body and that I could do things I did not believe possible until that next session. They caused pain (a necessary part of the journey), and they did all of these things with care and professionalism- despite my whining and sometimes less than positive attitude. For me, this is where the PT rubber hits the road. This is where the profession shines and has the successes that people talk about. I saw the real face of physical therapy, and I became a believer.

Then I began to wonder, what is that moment of shining for lab safety professionals? When do laboratorians become believers in lab safety? When does the safety rubber hit the road? What is that sweet spot that makes safety important to people?

I had a needle stick exposure early on in my career. It was before the advent of needle safety devices, and I picked up a used butterfly needle off of a bed and stuck myself in the finger. I was in a hurry, and not really paying attention. That event made me a much safer needle-handling phlebotomist- but would proper safety training have done the same? Would my risk tolerance have been different if someone had really explained the potential consequences of an exposure to me? Did the rubber hit the road for me because I had that experience? How does that get moved or changed so that safety behaviors become proactive instead?

I have hypothesized often that people will perform safely based on three motivators: knowledge about consequences, information about financial and environmental impacts, and punishment. Personal risk tolerance also plays a role, however. A technologist may be full well aware that an open specimen may splash, but they may also feel that the risk is low or that the result of a splash incident would not be severe, so they don’t use face protection. Sometimes, though, we make mistakes when deciding upon the risks, especially if we do not have sufficient education. Any open specimen is a potential exposure hazard, and all specimens should be treated as though hazardous.

In order for a lab safety program to have success, the working parts must be proactive. They must be in place to prevent injuries and exposures, and they should not be there only to figure out what to do after an event has occurred. When a program works in that proactive fashion, when staff is on board and participating, that’s when safety shines. That’s the safety sweet spot.

I’m thankful for professions that easily get it right- like physical therapy. People might not always see their value until they really need them, and that is when they shine. So maybe that’s true for lab safety – it shines when it is really needed. For lab safety professionals, then, the next step will be to get laboratorians to see that we need safety all the time.

A special thank you to Stephen, Audra, and the entire PT gang! You guys rock!

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

The Laboratory Safety Challenge

In 2014 there was an internet challenge which exploded in popularity. It was the ALS Ice Bucket Challenge in which people would dump cold water on their heads and post the video on social media. The person getting the ice water dumped on them would challenge others to post a video of their dousing and they would in turn donate to the cause of finding a cure for ALS, a progressive neurodegenerative disease. The challenge became a world-wide sensation and raised $115 million for ALS research. But, like many good things, the challenge had a dark side. Many people were injured while attempting the challenge, and at least two deaths were at least indirectly associated with it.

Another challenge has come to social media lately, and this one involves a technical skill in the laboratory. It, too, has a dark side. The blood smear challenge is the latest rage for lab techs who enjoy posting videos on Facebook, Instagram, and other social media platforms. Lab techs show off their skill by making the perfect blood smear. At first it was about who could make a smear with the most perfect beautiful, feathered edge. Then the challenge evolved into people making smears while holding the top slide with one finger or even a pencil. There are those who were quite proud to show off their skill and work.

When watching videos of people in various labs performing this challenge, I cannot help but cringe. Several of these lab techs are not wearing lab coats. Many are not wearing gloves, and I have not seen any perform the challenge while using face protection or goggles. Ignoring the safety regulations about using basic personal protective equipment is apparently the norm. These people post this online without a second thought to a public display of working in the lab without PPE. It speaks volumes about the safety culture in those laboratories, and what it says is not favorable.

The next, less obvious safety issue with the videos is that they are created using cell phones or other personal electronic devices in the laboratory. People are handling devices sometimes with gloves, sometimes without, or they are setting them on lab counters which are likely contaminated. The use of cell phones and other personal electronic devices is a dangerous infection control issue, but it is unfortunately all too common. Even before this latest challenge, lab staff all over the country pose for pictures for social media posts that are taken by cell phones. Despite the fact that known and reported infections have occurred in labs from cell phones (and other items brought home from work), techs continue to use them.  

Other issues with the blood smear challenge may be less obvious. Unless these smears are being used, valuable lab supplies are being wasted. Slides and blood-dispenser cap piercing devices cost money, and many lab supplies manufacturers have run into supply shortages this year because of the pandemic. To have a lab waste money or run into shortages for the sake of this challenge might seem foolhardy to some.

Another safety issue with the challenge is the blatant act of playing around with human, potentially infectious blood to make the smears. Staff use engineering controls, work practice controls and PPE to separate people from the hazards in the laboratory. To place oneself at risk unnecessarily, especially during the COVID-19 pandemic, borders on reckless.

When the COVID-19 pandemic began affecting labs over a year ago, many laboratorians became concerned for their own personal safety. They were unsure about how they might catch this virus and what effects it might for them and their family. These were valid concerns, and some still have fears today. In conversations with lab staff over the past months I reminded them that they work with bloodborne pathogens every day, and many are as potentially dangerous (or more) than the COVID-19 virus. If Standard Precautions are used on the job, workers will be safe from infections from COVID-19 and other pathogens. The same is true today. Laboratorians may be less worried about the coronavirus, but the risk of infection in labs from this and other pathogens is as real as ever. Using engineering controls, PPE, and safe work practices is the only way to ensure lab staff can go home without bringing something dangerous to our families.

Challenges can be fun. I participated in the ALS Ice Bucket Challenge. I came out unscathed, but I was likely just lucky, not safe. The same is true for those posting pictures and videos online from inside laboratories. You might have been working that way for years and nothing has happened. Again, that is just luck, and it will run out. Make sure you and your staff are doing what is right, and what is safe. The real challenge is how to get laboratorians in all labs to work safely and follow basic safety regulations. Can your lab meet that challenge?

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.

Truth or Consequences: The Wrong Question

It was with sadness that I watched the episode of Jeopardy! which featured Alex Trebek’s final appearance. While I hadn’t watched the game show consistently since 1984 when he first began to host, Alex had certainly become an icon in U.S pop culture and I had enjoyed watching him often. The quiz show has always been different than most- the answer must be given in the form of a question, and it must be the correct question in order to score points. As with most games, contestants don’t always ask the right question. That can happen with lab safety, as well.

I was performing an audit in a laboratory when the manager was bringing a new employee through during her orientation. I was introduced as the Lab Safety Officer, and I described some of my duties like auditing and safety compliance monitoring. The new employee immediately asked, “What happens if you catch someone not doing what they should?” That was the wrong question.

As an experienced lab safety professional, I often see people fail to follow certain lab safety regulations. Unfortunately, you do not have to look far to find lapses in lab safety practices. Vendors and service representatives and other visitors walk into labs across the country and lab staff ignore them. The visitors are not given information about the hazards in the department and they are not offered PPE. A look on social media will reveal multiple pictures of lab workers not wearing PPE as well. Oh- and they are taking those pictures with cell phones they shouldn’t be using (sometimes the hand holding the phone is gloved, other times it is not). While I am concerned about these unsafe behaviors, I am equally concerned about those that witness them and say nothing.

The COVID-19 pandemic has raised the public awareness of an important aspect of personal safety: the unsafe behavior of others can have a direct affect on your own safety. People who refuse to wear masks or who are sick and do not isolate themselves may create situations where the virus is spread to others. In the past year, many people have realized this and have felt empowered to say something to those who are not exhibiting safe behaviors. That realization that they may be in danger has made people feel comfortable speaking up for their safety and that of others around them. Perhaps that is what is needed in the lab setting as well.

Unsafe behaviors in the laboratory can easily have consequences that may affect many in the department. Spills and exposures are just some incidents that may occur. Messy lab areas can create trips or falls, and improper storage of chemicals or hazardous wastes can be dangerous as well. Perhaps laboratory staff don’t think enough about the dangerous consequences because there isn’t enough training about them. Perhaps they don’t think about the potential consequences to others because they haven’t been told about the possible physical, environmental, or financial consequences. When the new lab employee asked the question, “What happens if you catch someone not doing what they should,” I should have had an immediate answer. I should have said that she asked the wrong question. The real question is, “More importantly, what happens to you if you’re not doing what you should?” Teaching staff about the consequences of unsafe lab practices is something that should start on day one, and the awareness of these issues should be raised often and continuously. The truth is, it is important to correct your own unsafe behaviors, but it is also important to feel empowered to correct unsafe issues that are witnessed. The truth is, we all have a responsibility for our safety and that of everyone else who may be in the laboratory. If we own that responsibility, then no one’s safety has to be in…jeopardy.

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.

What to Expect When You Don’t Know What You’re Expecting: COVID-19 and Flu Season in the Laboratory

Welcome to October 2020 and a flu season unlike any other. What can we expect? Well, it’s complicated. And if we aren’t sure what to expect, can we still be prepared? Yes (at least for some things)!

From the beginning of the COVID-19 pandemic and throughout the summer of 2020 clinicians and laboratorians have been anxiously wondering what effect global presence of respiratory virus SARS-CoV-2 would have on the 2020-2021 flu season. “Flu season,” the annual, relatively predictable period of increased cases and deaths due to Influenza A and B, occurs during colder, winter months. In the northern hemisphere this is September through March. We have extensive experience tracking the onset and genetic variability of the predominant influenza viruses. We manufacturer flu vaccines based on data of potentially likely influenza strains. Other viruses that cause respiratory symptoms follow similar seasonal patterns. These include common (non-SARS-CoV-2) human coronaviruses, and Respiratory Syncytial Virus (RSV). In short: this is a known, annual occurrence that we can usually prepare to some extent.

So what will that look like this year? During the historic 1918 pandemic influenza, deaths seen during the first winter of the outbreak paled in comparison to those seen the following winter. Even if that kind of terrible scenario doesn’t occur during this pandemic year, it is possible we are facing “perfect storm” of COVID-19 plus influenza resulting in overwhelmed hospitals and depleted testing supplies. [https://www.cidrap.umn.edu/news-perspective/2020/09/fears-perfect-storm-flu-season-nears]

We know that COVID-19 spreads well in enclosed spaces with prolonged person-to-person contact, regardless of climate and temperature, via respiratory secretions. Because of this, there has been widespread adoption of mask wearing, social distancing, and limitations on in-person gathering. Promisingly, these interventions to prevent the spread of COVID-19 seem to be contributing to historically low influenza rates in the Southern Hemisphere! [https://www.cdc.gov/mmwr/volumes/69/wr/mm6937a6.htm] But adoption of these mitigation strategies are not being universally or rigorously followed in all regions and communities. As temperatures drop, we could see more people conducting activity indoors – will this change transmission patterns? Will regions with ongoing COVID-19 outbreaks be more prone to influenza as well? If hospital capacity becomes strained, will criteria for ordering tests change?

During COVID-19 laboratories have responded heroically and rapidly to test kit shortages, supply chain issues, and staffing challenges. At this stage (October of 2020) many high-level decisions about SARS-CoV-2 testing, like test platform purchasing and validation or manufacturer test kit allocations, might already be set in stone. So is there anything that can be done to help labs and laboratory workers successfully make it through flu season?

Here are 3 suggestions:

1) Establish testing algorithms and clear sample workflows.

Each facility and laboratory will have their own platforms for testing COVID-19 and other respiratory pathogens. Depending on the service ordering the test, there can be both immediate and downstream consequences for when a test comes back positive, negative, or even when that test result is slower than expected!

An algorithm helps set institutional expectations for what tests are ordered under different scenarios. For example symptomatic patients presenting to a hospital with influenza-like illness (ILI), especially when they will be admitted, should likely have both SARS-CoV-2 and influenza tests ordered simultaneously. But asymptomatic patients being admitted for procedures may only require a SARS-CoV-2 test.

Let’s say your lab has both a SARS-CoV-2 PCR test and SARS-CoV-2 rapid antigen test. But due to risk a false negative, lab and clinical leaders are uncomfortable using only a rapid antigen test to conclusively rule out COVID-19 in patients being admitted to the hospital. Your algorithm could use specify the use of SARS-CoV-2 antigen testing in symptomatic patients to quickly “rule in” potential positives, where antigen-negative patients will also have a PCR test. Algorithm specifics come down to what your institutions stake holders (clinical AND laboratory) need and capacity are. The details of an algorithm will be dependent on your lab test platforms, your available test orders, and may need to be modified to accommodate restricted test allocations.

Along with clinical algorithms, clear workflow for specimens and test types can help laboratory workers get tests where they need to go within the lab. Not all SARS-CoV-2 tests have approval in the instructions for use for, say, nasal swabs. If nasal swab comes to the lab with orders for both influenza and SARS-CoV-2 tests, what is the procedure for informing the floor for an appropriate collection? Or say that your test platforms for different tests live in different areas of the lab. Your workflow may be to set up one test and do a pour off into an aliquot tube so tests can be run at the same time. Or you may have sufficient test collection materials to request a separate sample for each test.

Probably the most important part of developing or reviewing your existing algorithms and laboratory workflow is doing it in connection with others. The purpose is to streamline the entire process from clinical decision making to test performing and reporting and help everyone be on the same page.

2) Communicate to clinical staff frequently about your tests.

Because of the intense interest surrounding COVID-19 laboratory testing, it’s entirely possible that more people have had to learn about previously niche laboratory concepts like “sensitivity vs. specificity” and “PCR vs. antibody vs. antigen tests” than at any previously time in human history! However, it is also likely that many clinicians or administrators in your own institution may know more about a test platform they read about in the news than the COVID-19 test platform that their laboratory performs.

Even at this stage in the pandemic with perhaps more exposure (pun not intended!) then the laboratory has ever had, miscommunication and unclear expectations abound surrounding test performance or turnaround times.

Whenever possible, lab leaders who interact with clinicians and administrators should look for ways to educate on test platforms, testing capacity, and expected test performance (i.e. time to result, comparative sensitivity etc.). This could include asking for time to provide formal updates during monthly meetings, monitoring test statistics (e.g. a test “dashboard”), or just informal reminders about what tests the lab performs during phone calls.

3) Keep the lab staff off the phone.

A critical part of the job of the lab is to provide information and updates on when test results are available. But when the hospital floors or clinics are busiest with patients, often the lab is busiest performing those patients’ tests. A phone call about the status of a respiratory virus test can be undeniably helpful to that patient’s clinical care team! But a dozen such phone calls over the course of a lab worker’s shift, especially under normal lab conditions (e.g. no staff shortages or instrument issues) is a failure of communication and can be detrimental to both lab performance and lab worker wellbeing.

In addition to the need for regular education about testing mentioned above, to help protect your lab staff’s bench time here are some possible ways keep from being overwhelmed with phone calls:

  • In some institutions, passive reminders (for example about hand hygiene or upcoming events) cycle through computer screen savers or on television screens in clinical areas. You could see if a message like “Reminder from the lab: COVID-19 tests are completed in [length of time].” could be put on a rotation.
  • If there is no client service or switchboard for your lab, but people call the lab directly for updates, you could institute a message stop. This is where phone calls routed to the laboratory must listen to a reminder that (for example), “If you are calling for an update of a COVID-19 test, these tests cannot be completed faster than [length of time] after arriving in the lab.”

    While these messages can be undeniably annoying and disruptive for people calling the lab for other reasons (and become less effective over time) if phone calls get out of hand, this option could be considered.
  • A lab instrument going down can result in test backlogs and numerous phone calls to the lab. Some institutions centralize their information in the form of a duty officer (for example in the emergency department). This will be a person who can be informed of actionable information, like test delays due to instrument issues, and who will post and distribute that information to those affected.

There is a lot we don’t know about what’s to come in the COVID-19 pandemic. While we can’t predict the ways the lab may be challenged with the next unforeseen disruption, or even what our flu season testing needs may look like, hopefully we can prepare now to continue to support our patients by helping and supporting our labs.

-Dr. Richard Davis, PhD, D(ABMM), MLS(ASCP)CM is a clinical microbiologist and regional director of microbiology for Providence Health Care in Eastern Washington. A certified medical laboratory scientist, he received his PhD studying the tropical parasite Leishmania. He transitioned back to laboratory medicine (though he still loves parasites!), and completed a clinical microbiology fellowship at the University of Utah/ARUP Laboratories in Utah before accepting his current position. He is a 2020 ASCP 40 Under Forty Honoree.

The Case for a Laboratory Quality Team

Maintaining a high level of quality is one of the primary goals of U.S. clinical laboratories. Sustaining quality is especially crucial during the often tumultuous and seemingly uncertain times that accompany hospital and healthcare systems mergers. According to an analysis by Kaufman Hall, there were 27 hospital and health systems mergers in the first quarter of 2019, representing revenue of $4.9 billion.  Mergers, acquisitions, and growth can be disruptive activities affecting finances, daily operations, and employee morale.

The majority of hospitals and healthcare delivery organizations have a quality department. However, the department is more often focused on the tasks and activities occurring outside of the laboratory. Furthermore, many hospital quality departments consist mainly of nursing or other clinical staff types and lack laboratory representation.

Often, despite the importance of test data, the laboratory’s role in a hospital’s quality department is usually limited.  If the laboratory is involved, it is frequently because a test result may have been involved in an event. Few hospital quality departments directly employ laboratory professionals.

Clinical laboratories must adapt to healthcare organization changes while simultaneously continuing to meet regulatory and accrediting standards. How can a laboratory ensure the changes do not affect the quality and remain “inspection-ready?” How does a large healthcare system standardize quality across multiple laboratories? The answer is a Laboratory Quality Team.

Laboratories are complex and highly regulated operations that must meet CLIA regulations and specific accrediting standards. A laboratory quality team comprised of seasoned laboratory professionals provides the healthcare organization with in-depth laboratory operations experience, real-world quality control knowledge, and practical understanding of regulatory and accrediting standards.

Another great benefit of a laboratory quality team is that their primary focus is on monitoring and maintaining quality in the laboratory. This benefit includes the ability to conduct root cause analyses (RCAs), reviewing and ensuring validation of new tests and instrumentation, and conducting internal audits.

The value of having a dedicated laboratory quality team is readily apparent in mergers, especially when one of the goals of the merger is to streamline processes, standardize operations, and reduce waste.  A laboratory quality team is a perfect tool to conduct a gap analysis between different laboratories to determine the best and most cost-effective processes and procedures to retain.

A dedicated laboratory quality team is an invaluable asset for a healthcare organization operating multiple labs (particularly those in different states). The team can organize and coordinate quality-related activities and performance improvement initiatives. Assessing the level of compliance across laboratories and preparing compliance-related reports would be a primary responsibility of these individuals. The team would also be directly involved in developing, revising, and validating laboratory quality administrative policies and procedures.

As an outcome of new knowledge and scientific breakthroughs, laboratory accrediting bodies are continuously updating standards governing laboratory operations. A laboratory quality team can research and provide clarity on regulatory mandates and accrediting standards. The team can also be a resource on how changes in standards may affect laboratory operations and evaluate whether current procedures or processes need to be updated or eliminated.

Customer service is an essential aspect of laboratory operations. Beyond patients, laboratories serve physicians, nurses, and other healthcare providers. The laboratory quality team can represent the lab when interfacing and collaborating with leadership, interacting with medical and laboratory staff, and is especially suited to interact with lab inspectors.

The laboratory quality team’s minimum qualification should be a bachelor’s degree in a physical, chemical, biological science or medical technology and at least two years of clinical lab experience. However, a more robust set of qualifications would include experience as a clinical laboratory inspector, additional auditor certification (for example, those offered by the American Society of Quality), and personality and skills geared toward researching, learning, and presenting.

Mergers, consolidations, and acquisitions will continue in the healthcare industry as the marketplace environment challenges organizations’ bottom-line. Laboratories are an integral part of hospitals and other healthcare organizations seeking to deliver high-quality services to the community. Lab administrators and managers need to adapt operations while sustaining a high level of quality. A laboratory quality team composed of seasoned, knowledgeable, and motivated professionals can help laboratories navigate the inevitable regulatory, accrediting, and personnel changes unavoidable in the dynamic healthcare industry.

-Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.

Safety Checklists and High Reliability in the Lab

A High Reliability Organization (HRO) is one that works with complex and hazardous systems every day and yet retains a high level of safety and an error free environment. The first recognized HRO industries were the United States Navy nuclear aircraft carriers , the Federal Aviation Administration’s Air Traffic Control systems, and nuclear power plant operations. These industries operate using highly complicated and dangerous processes, yet they have the fewest safety incidents.

The use of checklists is an important part of keeping safety incidents to a minimum. They can help employees avoid safety issues, avert disasters, and even aid in incident response. In aviation, a pre-flight safety checklist is a list of tasks that must be performed by pilots and crew before a take-off. Pilots also use checklists for both normal and non-normal operations, for landings, take-offs, and also for malfunctions, and emergencies. Checklists are usually printed on a card, and one card may be divided into as many as a dozen of separate checklists, each of which will be read aloud depending on the phase of a flight. Nuclear power plant operations also involve the use of many safety checklists.

A functional safety checklist features specific characteristics that aid the user in avoiding safety mishaps. Checklists should have defined pause points so users can determine when the list should be used and when new tasks should begin. Checklists types are also important, and the style used may vary depending on the task and the experience of the user. For example, a “do-confirm” list is generally used when users are experienced with the process and have gone through the necessary steps on the list and simply run through it to ensure the process is complete. A “read-do” checklist means employees perform the tasks as they read through each list item.

Most checklists should not be lengthy as it may tempt experienced users to take shortcuts or to ‘pencil-whip’ responses. Make sure the list includes crucial and potentially overlooked steps. These may be the things that can cause the greatest harm if not checked. Use language that is simple, precise, and use terminology that is familiar to the lab staff using the list. Lastly. Test the checklist to see that it fits the criteria above, and that it accomplishes the task set for it. The real goal of using a safety checklist is to create a cultural change by enhancing teamwork, increasing safety communication and changing the understanding of responsibility for safety within the department.

There are quite a few published lab safety checklists available for use. Here are just a few:

  • CLSI’s Clinical Laboratory Safety (GP-17) – Lab Safety Checklist (Appendix C)
  • World Health Organization Biosafety Manual (2004)– Ch. 22 Safety Checklist
  • ISO 15190 Medical laboratories: Requirements for Safety (2019) – Annex B
  • EPA website: Waste Generator Inspection Checklists

Your lab may have its own specific needs, and these checklists may not cover them, or they may be too much for your current issues. If that is the case, create a checklist that focuses on an issue or issues you’d like changed. For example, if PPE compliance is on the rise, create a list that can be used daily or weekly. Walk around and look for proper footwear, lab coat use, and face protection for example. Home made checklists can be scored and used as a quality monitor in order to show improvement in lab safety over time. Make sure people are trained to use the checklists properly, and that people are consistent in how they answer individual items. It’s always a good idea to alter who uses the safety checklists as well. Make sure everyone can use them, and that will create a broader understanding of the safety needs of the department. That can go a long way toward improving the overall safety culture. A review of checklists is always key. If there is a problem with a response for a particular item, it should never be ignored. In fact, it should be addressed quickly.

Many labs today do not fall into the category of a High Reliability Organization. Complex and dangerous tasks do occur in the field, but safety incidents are not uncommon. It may be because lab employees are not educated enough about the consequences. There are definite hazards when working in the lab setting, but often they are not in the forefront of the lab techs’ minds, safety is not made a priority. It needs to be discussed more. Or maybe the reason is that many of the hazards in the lab do not always have more immediate consequences. Organisms involved with exposures have incubation periods, and disease states (like cancer) can take years to develop after a safety incident.

In the airline and nuclear industries, if a safety error is made, the consequence is usually immediate, and deadly for many. Is that it? Is that why people don’t have the same reaction to safety issues in the lab? What can we do as safety professionals to change that? I believe we can change it- and it will take checklists, training and safety awareness.

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

The Laboratory’s Role in Inclusion

“Where do we go from here…chaos or community?” is the question Dr. Martin Luther King, Jr. asked in 1967 before the civil rights riots in the hot summer of 1968.  The query was directed to the nation as it sought to address the racism and pain deeply felt in the daily lives of its African-American citizens.  Over 50 years later, that very same question is asked again as the nation is roiled with civil demonstrations, daily videos of racist behavior, and the seemingly senseless killings of African-American men and women. 

As American culture and the nation evolves, uncomfortable conversations are beginning to occur in healthcare and across the country.  Laboratory administrators and managers may want to reflect on the culture of their laboratory to ensure all voices are heard and that they are creating and supporting an inclusive work environment.

Diversity, inclusivity, and equity are goals healthcare organizations seek to incorporate into their culture to foster a healthy workplace environment and be reflective of the communities they serve.  As with most industries, the laboratory has found itself challenged to improve cross-cultural intelligence and eliminate implicit and unconscious bias.  The scientific community would like to believe it operates and makes decisions based solely on objectivity and facts.  However, everyone is human and prone to perceptions influenced by preconceived beliefs and life experiences. 

In the laboratory, questions involving race relations are pondered and discussed by workers of all creeds and colors.  Historically, laboratorians have viewed themselves as scientists focused strictly on the pursuit of facts, hard data, and helping patients.  However, one would err in thinking the lives of minority lab workers were encased in impenetrable bubbles of logic and reason. Instead, early on in their career (correction—their lives), many minority workers learned to compartmentalize and hide feelings of unfairness and helplessness in their effort to “fit in” and not make others feel uncomfortable.

Laboratory administrators should let employees know that their office is a “safe place” if an employee feels he or she needs to discuss issues affecting how they feel about their work environment. Many employees of color working in predominately white environments may avoid conversations involving race out of fear as being labeled as “one of those.”  However, avoiding difficult conversations does not make the problems go away; in fact, the lack of addressing an issue often creates a more significant problem later on, or the employee simply quits.  One thing managers should be prepared to hear if they are successful in creating a safe space and the employee chooses to talk, harsh truths.

Lab managers can be proactive and ask if the employee has encountered any barriers or obstacles to their success in the healthcare organization.  Minority employees frequently experience microaggressions, favoritism, and racial discrimination.  Discussing feelings may provide a release for the employee, allow the manager to begin to understand, and offer the opportunity for the manager to reflect on their behavior. 

 The diversity of today’s protest marchers provides evidence of the progress America has made toward vanquishing the problems of racism and discrimination.  All colors, creeds, and ethnicities are together expressing their desire to defeat the scourge of racial injustice.  Laboratories are a part of the social community, and minority employees are often reluctant to share anxiety and experiences they feel are race-based.  Lab managers should be reflective and reach out to their employees to let them know their office is a “safe place” to discuss issues openly, including those with racial overtones.  It is only through open and honest dialogue that we can avoid chaos and become the community we seek.

Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.

From Panic to Pandemic: Laboratory Emergency Response Plans

In 2018, Hurricane Florence ripped through the Carolinas causing an immense amount of destruction and taking a record amount of lives in the area. Superstorm Sandy had a devastating impact on New York and New Jersey in October 2012. In Joplin, Missouri, an EF-5 tornado cut a damaging path through town in May 2011, directly hitting the hospital. Severe storms, flooding, and even blizzards are regular events throughout large areas of the United States every year, disrupting normal life and the delivery of services, including healthcare services.

Natural disasters occur frequently, and labs must consider them in their Emergency Response plans. These disasters have consequences for hospitals and laboratories and their operations. Given the wide variety of possible disasters that can affect a laboratory, it may seem impossible to be prepared for every type of event that could occur. Some labs take a reactive approach and create individual plans for different disaster types. For example, a lab manager may decide to create a blizzard response plan after a major winter storm—a plan that is separate from any previously existing lab emergency response plan. That may not work well, and it many plans may become cumbersome for lab staff when the event occurs.

As 2020 has shown us, other types of disasters that are not normally considered can also affect laboratory operations. The COVID-19 pandemic situation has created issues like the reduction of the availability of staff, a need to quickly alter testing platforms, and even major supply acquisition issues. Clearly, pandemic issues need to be considered when looking at lab disaster responses.

The best type of laboratory emergency response plan is a single plan that will enable the laboratory to continue to provide services in a variety of disaster scenarios, including pandemics. The College of American Pathologists (CAP) requires labs to develop an emergency plan which is based on the overall facility’s Hazard Vulnerability Analysis (HVA). The HVA is a risk assessment tool that lists types of disasters that can affect the facility, and it ranks which disaster types are most likely. If you work in an independent lab, you must perform your own HVA and update it every year. In 2020, it would be prudent to quickly add “pandemic” to the list.

There is no need to panic, however. In your plan which has been designed to have an “all hazards” approach, you may find some aspects of pandemic response are already addressed. Fluctuating staffing levels should already be addressed. Be sure the plan discusses how to best utilize staff when fewer people are available. That process may include a reduction in testing or utilizing a reference lab if necessary. In some instances during the pandemic, labs were left with too many staff members once an overall reduction in lab volumes occurred. How can extra staff be used? Can they go to other departments or facilities where needs may exist? There should be a section in the response plan regarding how to handle supply issues. If it is known there is going to be a problem obtaining PPE, reagents, and other supplies, decide what procedures will occur. Stockpiling, finding alternative vendors, and changing the type of supplies purchased are some options.

Once all of the pieces of the updated lab emergency operations procedure is complete, it is important to test the plan for flaws or needed improvements. One thorough method of testing includes the use of a table-top drill or exercise. Present a step-wise disaster scenario to key lab stakeholders and discuss possible responses as the imagined situation unfolds. Be sure to discuss important aspects such as staffing, supplies, communications, and relocation of testing. If the COVID-19 pandemic has led your lab to utilize its emergency response plan, be sure to take the opportunity to review how it is working for your department. Ask lab leaders and staff members if the current plan works- what went well and what needs improvement? This current disaster can help us all to improve our current procedures and keep us ready for the next event.

Is your laboratory emergency operations plan up to date? Does your staff know how to use it or will they panic when a disaster occurs? Has the plan been tested? Now is the time to review what you have and make sure it works for pandemics as well as a wide variety of disaster scenarios.

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.