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.

How One Phlebotomist Can Positively Influence Patient Care

Can you remember where you were when an experience showed you who you could be? I do. After graduating college, I wanted to find a way to harmonize my passion for community with my need to make an impact on society, so I began volunteering at the University of Colorado in the Cardiac Intensive Care Unit. I had an experience there that inspired me and has shaped my career’s trajectory.

During one quiet day on the unit a phlebotomy technician approached me with a task: to obtain a couple positive and uplifting movies for a patient who would most likely not make it through to the next day. Confident in my ability to achieve this, I hurried down to the volunteer office. As I looked through the selection of DVDs, I became disheartened. Nothing in their collection would do. All I could think was that this patient was living his last moments, and I couldn’t provide a happy distraction.  When I returned, my sorrow was quickly reversed when I found the technician by the patient’s bedside, using her phone to watch his favorite movie with him. I was so moved by her compassion,  I hosted a DVD drive to collect positive, uplifting movies for situations like this

I called numerous radio stations to get the word out and was featured on the local country radio station’s morning show to announce my drive and mission. My volunteer position, in combination with my customer service job, had allowed me to develop a large clientele and access to a community willing to help me in my efforts. I was touched by all the patrons who passed out flyers in the neighborhood about the drive. I ended up collecting over 200 DVDs, which I proudly delivered to the volunteer office. This intersection of medicine and community allowed me to experience firsthand the power of compassion in the medical community. I discovered my profound ability to bring together a community of unlikely individuals in an insightful and moving way. This experience also made me think seriously about the possibility of becoming a phlebotomy technician.  

Four  months, later I was practicing the art of phlebotomy in a hospital setting. As a phlebotomist I was doing more than drawing blood; I was learning the fundamentals of healthcare such as patient privacy, patient advocacy, and how to prevent the transmission of disease. I learned the importance of diagnostic and laboratory testing, how blood samples can provide clues to diagnosis and treatment.  Over the years my patients have shown me the meaning of tragedy and triumph, hope and disappointment, and most of all, the importance of being kind and gentle to those who are sick and in need. After drawing blood for more than 5 years with nearly 15,000 hours of patient care experience, I’ve learned the duty of a phlebotomist extends beyond the needle. It requires passion for diagnostic testing, patient education, patient advocacy, as well as dedication and commitment to others, to opportunities to learn, to engage in team collaboration and the ability to provide passionate medical care. Phlebotomy allows you to approach medicine with a multidisciplinary mindset and the ability to work in a medical community with a discourse of many facets under the unified goal of improving the quality of life across communities both nationally and abroad. 

Before I witnessed the compassionate care of a phlebotomy technician, I was unsure of how to combine  my passion for community with a rewarding career. In witnessing such compassion and care beyond duty, I was inspired to help, which ultimately inspired a community. That one experience showed me who I was supposed to be and what I am today – Kristi Nelson, Clinical Laboratory/Phlebotomy Coordinator.

That first experience now serves as the standard of care for my own phlebotomy team. I ensure we provide patient care that extends beyond the expectation, care that inspires change and creates a butterfly effect of positivity and compassion, in the same way that the phlebotomist had inspired me. This is just one example of how a phlebotomy interaction not only with a patient, but with other medical professionals (volunteers included) can influence patient care and the future of medicine in a positive way.

-Kristi Nelson is a Laboratory Coordinator for the Clinical Laboratory, Client Services and Customer Support at Orlando Regional Medical Center. It was through her work as a certified phlebotomist and emergency medical technician that Kristi found her passion for the healthcare community and leadership. Kristi’s leadership style follows the belief that if your actions inspire others to, learn more, do more and become more then you are a leader. Kristi demonstrates her passion for leadership by participating as the Compliance & Ethics Ambassador, Orlando Health Way Ambassador, and spokesperson for Orlando Health’s volunteer campaigns for the laboratory. Kristi holds a BA in Women’s and Ethnic Studies from the University of Colorado. Kristi is completing her BS in Neuro Psychology from the University of Central Florida and a dual Masters of Business Administration and Science Management and Leadership from Webster University.

Unwritten Safety Rules Every Lab Professional Should Know

Many years ago a woman purchased a cup of coffee in a restaurant drive-through. Not having a cup holder available in her car, she placed the cup between her legs to hold the coffee while she reached for money to pay for it. She burned her legs, sued the restaurant, and actually won her court case. Now such restaurants are required to warn customers with signs stating the obvious; “coffee served hot.” Before this regulation came to be, however, many people were aware of the possible danger of placing a hot cup near their skin. Does having a posted sign make customers safer? What about the lab environment? There isn’t an explicit safety regulation written for every action that could create an unsafe situation. So what are a few of the hidden and maybe no-so-obvious things might your staff need to know in order to keep safe?

You can’t chew gum in the laboratory. It’s true, but sadly, it’s not written down anywhere as a regulation. OSHA’s Bloodborne Pathogen standard says that “eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited (in the lab).” It says nothing abut gum, throat lozenges, hard candy, or even chewing tobacco. The unwritten rule is that OSHA is trying to prevent hand-to-face contact while working in an area where infections can be acquired easily this way. There are multiple routes of entry via mucous membranes- a major source of pathogen exposure- your mouth, nose, and eyes. Laboratorians should always keep their hands away from their face when working in the department. These activities are just another opportunity for hand- to-mouth contact. While you might be able to show the safety officer you are putting these things in your mouth outside of the lab, you would not be able to prove that to an inspector, and they will rightly cite you for it. If you need help enforcing this, be on the lookout- by the end of the year there will most likely be a regulatory body that addresses gum chewing directly.

How long should staff wear PPE? During the COVID-19 pandemic, many have asked about the effectiveness of various PPE and have looked for written guidance discussing how long it should be worn. In general, studies show that gloves lose barrier effectiveness in about two hours. Wear them that long if they are not visibly soiled while in use in the lab. Lab coats- disposable or reusable- can be worn for one week in the general lab setting unless something is spilled on them. Once a new coat is worn, the outside is considered contaminated, but that does not mean it cannot be re-used. It is wasteful to change coats every day unless there is a reason to do that (i.e. in a specialty lab where cross-contamination will be an issue). Face shields worn by staff can be reused as well, and they can be cleaned with alcohol-based products for disinfection. Rarely should a wearable face shield or goggles be used only once before disposal.

Mesh shoes are not allowed to be worn by lab personnel. Again, other than in CLSI guidelines, it will be difficult to find that written clearly in lab safety regulations. Laboratory footwear should “be comfortable and cover the entire foot, including the instep and the heel. Because canvas shoes will absorb chemicals or infectious fluids, they are not recommended. Leather or a synthetic, fluid-impermeable material is suggested. OSHA’s PPE standard does insist that employers take measures to protect the feet of employees. In the lab and specimen collection setting, that means footwear needs to protect from biohazard materials, chemicals, and even sharps. Mesh or canvas shoes do not fit the bill, and neither do clog-style shoes (even if they have a heel strap). If you need to, set your lab’s footwear policy through the dress code or maybe the Chemical Hygiene Plan. If staff tells you they can’t find this type of footwear, tell them to look harder. All across this country, hundreds of laboratory employees are wearing the appropriate shoes, and they are available at several different stores.

Often, because these safety rules are “unwritten,” staff will challenge you on them. It can be difficult to try to enforce these important safety measures if you can’t properly educate the staff about why they exist. Be sure to know your regulatory resources, and don’t be afraid to dig deeply into the references to find the answers you seek. Lab leaders can write their own policy, and it can go above and beyond what the regulations state if needed. The safety standard may not be clear and direct, but it these are still important measures to take. Just like that lady may have needed a sign to prevent her from putting hot coffee in her lap, your staff needs clear safety guidance to keep them safe from a lab-acquired injury or exposure. Provide the tools they need to remain happy and healthy members of your lab team.

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.