The Three Biggest Safety Audit Blunders

There are several potential safety indicators that can be used to help someone assess the effectiveness of a laboratory safety program. The results of a properly performed safety audit can be one of those indicators, and it can provide useful information to a lab safety professional whether he or she is new to the role or has been there for years. You’ll note, however, that the term “properly performed” was inserted, and that was no mistake. Safety audits are performed in laboratories across the world, but in some of these locations the environment remains very unsafe, and performing the audits hasn’t made any difference. Mistakes can be made when performing a laboratory audit, and those errors can lead to dangerous situations. While all audit errors need attention, there are three that can cause the most damage to your lab.

Probably the most common safety audit gaffe is a practice known as “pencil whipping.” This happens when someone quickly marks “yes” on every single item of the safety checklist without really checking for compliance. Pencil whipping occurs for many different reasons. The person performing the audit may be in a hurry, they may feel like they have performed the audit often and just know the answers, or they may just not care about the audit results. Perhaps there is no lab leadership oversight as to how the audit is performed, or maybe the person performing the audit doesn’t understand what the checklist items mean. No matter the reason, this pencil whipping of answers is dangerous. It provides false results, and it masks real safety issues in the department that will likely not have resolution. In an environment where this occurs, a preventable lab injury or exposure is likely to occur, and it could have lasting or even career-altering repercussions for the victims.

Another safety inspection misstep occurs when the person performing the audit begins going down the checklist with pre-conceived assumptions or a specific focus in mind. Some auditors have their minds made up about a lab safety culture before they start, and their version of what they see while inspecting may be skewed. That may cause them to cite a lab falsely and without enough investigation into a particular issue. Some inspectors might be so focused on one thing- chemical labeling, for example – that they miss other obvious safety issues such as trip hazards on the floor. This narrow focus or mindset can limit the effectiveness of a safety audit as it can prevent the auditor from noticing other real hazards in the laboratory.

The third safety audit blunder (and probably the one with the worst consequences) is a failure to follow up on the audit results. In a larger laboratory, a complete lab safety audit can take several hours. It may involve a procedure review, an employee file review, and a look through lab drawers and cabinets as well as a walk-through. However, even if all of the findings from that work is well-documented, it won’t mean anything if there is no follow-up. A failure to review and act upon audit results negates the entire process, no matter how well it was performed. Make sure your lab inspection method includes that final step – someone should review all results and ensure that any safety issues are addressed or resolved as soon as possible. A healthy lab safety cycle will include that review as well as repeat audits to make sure safety compliance is maintained on an on-going basis.

A properly performed audit can speak volumes about the overall lab safety program. If your audit form remains constant, it can be a good idea to train multiple people to perform the audit so the lab can be viewed with fresh eyes each time. Regardless of who performs the safety audit, make sure they refrain from pencil whipping, that their focus is not narrow, and that the person responsible handles the follow up of any safety issues discovered. By avoiding common audit blunders, a positive improvement of the lab safety culture can be assured.

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.

Potassium Levels in Transgender Women

For transgender women, taking pills of estradiol is insufficient to counteract the endogenous levels of testosterone produced by their bodies. To counteract the undesired testosterone, anti-androgens are employed. These include cyproterone acetate (approved only in Europe) or spironolactone. Spironolactone is a potassium sparing diuretic that could have unintended consequences like gynecomastia.1 This effect comes from off-target binding of spironolactone to the androgen receptor. Like the intended spironolactone target (mineralocorticoid receptor), the androgen receptor localizes to the nucleus when activated and acts as a transcription factor. Taking daily high doses of spironolactone (100mg- 300mg daily) has been shown to be safe,1 but can increase Potassium levels. In a cohort of 55 transgender women, potassium was actually not higher (Figure 1).2 This was the first time a study had rigorously measured electrolytes like potassium in transgender patients. Current guidelines recommended checking electrolyte levels in transgender women taking spironolactone.3 Full electrolytes were included for 126 TW in our study and what we found was not what we were expecting.4

Figure 1.

We found no increased potassium levels in TW who had taken hormone therapy for at least 6 months (p>0.05). However, we did see a decrease in sodium which is consistent with the diuretic effect (p<0.0001, Figure 2).

Figure 2.

We wondered if variability in spironolactone dosing could explain why no significant potassium change was found. Luckily, we had a large number of patients who were taking various doses of spironolactone for comparison. One-way ANOVA with Tukey post-hoc tests revealed no difference in potassium levels (p>0.05)- even between the lowest (0mg daily) and highest dose (200-300 mg daily) (Figure 3). While the sodium level trended to decrease with higher spironolactone, it was not statistically significant.

Figure 3.

One reason that potassium levels did not increase is a difference in study populations. The original population studied for spironolactone involved patients with heart failure and hypertension whereas our study’s population was mostly in their 20’s and 30’s with very few co-morbid conditions.

Although sodium levels are decreased, they did not fall below the lower limit of normal (135 mmol/L). Low sodium would put transgender women at risk of dizziness and syncope (passing out) from low blood pressure. Thus, the takeaway is: sodium should be clinically monitored as it can decrease in transgender women.

References

  1. Clark E. Spironolactone Therapy and Gynecomastia. JAMA. 1965;193(2):163-164.
  2. Roberts TK et al.  Interpreting Laboratory Results in Transgender Patients on Hormone Therapy. The American Journal of Medicine. 2014; 127(2): 159-162.
  3. Hembree WC, Cohen-Kettenis PT, Gooren L, Hannema SE, Meyer WJ, Murad MH, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2017
  4. SoRelle JA, Jiao R, Gao E et al. Impact of Hormone Therapy on Laboratory Values in Transgender Patients. Clin Chem. 2019; 65(1): 170-179.

-Jeff SoRelle, MD is a Molecular Genetic Pathology fellow at the University of Texas Southwestern Medical Center in Dallas, TX. His clinical research interests include understanding how the lab intersects with transgender healthcare and advancing quality in molecular diagnostics.

Just Culture: Growing Trend or Lab Requisition?

Hello again everyone!

Last month, I discussed some really interesting topics at the intersection between psychiatry and pathology—two fields that aren’t exactly the closest; more so “diverged” in the hospital milieu as if in a poem by Robert Frost. This month I’d like to bring the conversation back to a topic I’ve addressed before: improving multidisciplinary medicine and creating a Just Culture in medicine.

Not exactly culture with a swab or agar dish, a Just Culture is an all-encompassing term for system-based thinking and process improvement not at the expense of individuals. In a post I made last July, the topic of high reliability organizations (or HROs) is one that addresses communication and accountability in high stakes environments—like healthcare!

Just Culture isn’t a stranger to lab medicine. The American Society of Clinical Laboratory Science (ASCLS) published a position paper in 2015 utilizing this trending healthcare buzzword. On the subject of patient safety, ASCLS believes “Medical Laboratory Professionals must adopt a ‘fair and just culture’ philosophy, recognizing that humans make errors, and understanding the science of safety and error prevention.” (Source: ASCLS 2015, https://www.ascls.org/position-papers/185-patient-safety-clinical-laboratory-science) We all know how we maintain patient safety in the lab, right? We do that through quality control, QA measures, competencies (both internal and from accrediting bodies like CAP), and continuing education. Raise your hand if your lab is getting inspected, just finished getting inspected, will be inspected soon, or if you’ve recently done competency/proficiency testing yourself, CE courses for credentialing, or are reading this blog right now! We’re all “continuing” our education in health care ad infinitum because that’s how it works—we keep learning, adjusting, and ensuring best practices concurrent with the latest knowledge. And, instead of punishing lab professionals when we make errors, we try to be transparent so that each error is a learning opportunity moving forward.

Image 1. I’d panic too if my lab was being inspected by 007. What, you wouldn’t?

I’m currently in my OB/GYN rotation at Bronx-Care and during the most recent Grand Rounds we had someone talk about “Just Culture”—a sort of continuation on the themes of the same lecture series that inspired my article on HROs. Essentially, the theme is that disciplining employees for violating rules or causing error(s) in their work is less effective than counseling, educating, and system-oriented and best-practice-informed care. In this talk, we watched a short video (embedded below) which walked us through approaching faults or errors in medicine in a way that empowers and educates. A story from MedStar Health, a Maryland-based health system, demonstrates how systems-based thinking can be the best way to solve problems in healthcare.

Video 1. “Annie’s Story” has become a widespread example of Just Culture for nearly twenty years. Being serious about high reliability and just culture means adopting a system’s approach to analyzing near misses and harm events—shame and discipline are becoming antiques. Learn more about Quality and Patient Safety (http://ow.ly/M1aZk) and Human Factors Engineering in Healthcare (http://MedicalHumanFactors.net)

Annie, a nurse in the MedStar Hospital system, is the spotlight story in this video. She came across an error message on a glucometer after checking someone who was acutely symptomatic. She double checked it and made clinical decisions, with her providing team, to give insulin. This sent the patient into a hypoglycemic event which required ICU support. In the story, she was actually suspended and reprimanded for her “neglect”—other nurses made the same error just days later. This prompted some action, inciting nursing managers and other administrators to investigate further, ultimately involving the biomedical engineers from the company to weigh in on this systemic fault in glucose POCT. Annie returned to work, and the problem was recognized as not user-error, but system error; she went on to talk about how she felt unsure of her clinical competency after being reprimanded. Imagine if you accidentally reported the presence of blast cells in a manual differential in a pediatric CBC while you were alone on a night shift only to find out from the manager on days that you made a pretty big mistake with clinical implications. Then imagine you were suspended for a few weeks instead of simply asked to explain and identify opportunities to increase your knowledge. Pretty harsh, right? I’m glad the MLS who did that didn’t lose his job and only had to do a few more competency trainings…yep.

Fine. It was me. I mentioned mistakes in my discussion on HROs and discussed that particular mistake in part of a podcast series called EA Shorts with a clinical colleague of mine. Everyone makes mistakes, especially in training, and that’s okay! It’s how we deal with them that matters.

Image 2 (a, b). Take a look at that glucometer. Would you have caught the error? Did you catch the “LO” value in the background vs. the out-of-range foreground prompt? Or was the screen prompt as distracting for you as it was for Annie? Who was responsible for this error: nurse, lab, or engineer?

Anyone else notice a stark absence of professional laboratory input in the video? I assume many of you sharp-sighted lab automation veterans didn’t miss the glaring “LO” behind the dialogue box on the glucometer. And, to me, that begs the question: was there any lab input on this instrument, its training, or its users? Nurse Annie made a mistake—but she’s not alone, according to a Joint Commission study from November last year, close to 11% of users make mistakes when prompted with error messages compared to 0% of users misinterpreting normal values on screens of a particular model of glucometer. And that’s just one type of instrument. Imagine 1 in 10 nurses, medical assistants, or patients misinterpreting their glucose readings. (Source: The Joint Commission Journal on Quality and Patient Safety 2018; 44:683–694 Reducing Treatment Errors Through Point-of-Care Glucometer Configuration) This should also be a good opportunity to remind us all of CLIA subpart M, the law that outlines who can accredit, use, and report point-of-care results. Herein lies another problem, stated well by the American Association for Clinical Chemistry (AACC) in 2016, “… another criteria for defining POCT—and possibly the most satisfactory definition from a regulatory perspective—is who performs the test. If laboratory personnel perform a test, then this test typically falls under the laboratory license, certificate, and accreditation, even if it is performed outside of the physical laboratory space, and regardless of whether the test is waived or nonwaived. On the other hand, waived or nonwaived laboratory tests performed by non-laboratory personnel are nearly always subject to a different set of regulatory and accreditation standards, and these can neatly be grouped under the POCT umbrella,” and that can mean trouble when we’re all trying to be on the same clinical page.

In previous posts, I’ve mentioned the excellent knowledge contained within the Lab Management University (LMU) program. One of the modules I went through discussed this topic exactly: Empowerment as a Function of Leadership and Peak Performance. In short, if we want to be good leaders in the lab, we have to set expectations for positive patient outcomes, including safety. Good leadership should empower their staff with education, support, and resources. Poor management can create toxic environments with staff that can be prone to mistakes. If we can be dynamic leaders, who adapt to ever-improving best practices and respond with understanding and compassion to mistakes, then our colleagues become just as reliable as your favorite analyzer during that CAP inspection I mentioned.

Image 3. LMU class module for promoting Just Culture and inciting positive behavior in your department.

I often get clinician input about how the processes between the bedside and the lab can be improved. Often, they include comments about the need to share relevant clinical data for improving diagnostic reporting or improving a process between specimen collection and processing. But what often gets left out is the human element: the scientist behind the microscope, the manager behind the protocol, and the pathologist behind the official sign out report. Let’s continue to incorporate all of the feedback our colleagues provide while maintaining a safe and empowered culture for ourselves, our staff, and our patients.

What do you think? How does your lab, hospital, clinic, etc. address POCT safety or patient safety at large? Do you operate within a Just Culture? Share and comment!

Thanks and see you next time!

–Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student actively involved in public health and laboratory medicine, conducting clinicals at Bronx-Care Hospital Center in New York City.

Working With Baby Boomers: How Other Generations Can Adapt

Baby Boomers were for a long time to largest working generation in the workplace. They are slowly retiring and the next largest generation, Generation Y, is becoming the largest. However, Baby Boomers’ impact on the workplace is still profound and most organizations, if not all, are currently employing many Boomers. They are likely to be working in leadership roles and exert influence on many policies, procedures, systems, and organizational cultures.

Similar to Traditionalists, Baby boomers also appreciate face-to-face meetings. However, their preference for leaving and receiving voicemails is a lot higher than Traditionalists. They also appreciate social media more, especially as their children and grandchildren are using it. Baby Boomers utilize the internet more than Traditionalists and send text messages, even if they still prefer to talk over the phone instead of texting.

Working with Baby Boomers is all about the relationship. Establishing interpersonal connection should therefore be one of your main priorities when collaborating with someone from this generation. Because of the personal nature of their working style, it can sometimes take a few weeks (or longer) for decisions to be made. Calculate that in when working on a proposal or project. Baby Boomers appreciate formal presentations and a consensus-based process.

A Baby Boomers’ approach to leadership centers on incentives, data-driven decisions, and a democratic process. They typically are open to input from peers and their leadership style is friendly. They value receiving recognition, so any award or reward is appreciated and they will often display them publically. Because of their focus on interpersonal relationships, they do not respond to people who are not friendly and who indicate their hierarchy. Instead, make sure that they feel you are listening to them and including them. One way to do this is by taking notes and asking follow up questions.

Baby Boomers’ professional dream is continuing to be useful and productive in the workplace while feeling they are wanted and rewarded. If you want to increase your working relationship with Baby Boomers, connect with them on an interpersonal level by inviting them out to lunch and get to know who they are outside of the workplace. Provide them with positive affirmations, recognitions, and awards to make them feel they are a valued members of the organization and that they input and work is essential to producing results. Baby Boomers bring a lot of patients, experience, and knowledge and they help create and foster a team environment when they feel they are contributing members of the organization. Do not show impatience and question their ways of doing things openly. If you do need them to change something, include them in the process to make it a consensual and democratic process. Adding a Baby Boomer to a team can greatly improve the outcomes and success of that team.

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


I’d like to tell you a story that happened at the ASCP Annual Meeting last October, 2018 in Baltimore.

Lotte Mulder and I presented a course on “Discovering Your Diversity Strengths” to about fifty people. Lotte is a Millennial and I am a Baby Boomer, and we’ve been working closely together for over three years on a daily basis. The presentation went really well and the audience was very participative and interactive. We talked about how different we were, how we complimented each other, and the value of human diversity in the workplace. 

At noon that day, we both participated in a Lunch Roundtable where the topic was Diversity in the laboratory. We quickly learned that those at our table had a strong interest and frustration about working with people from different generations. The focus was primarily on Millennials and Boomers. There were eight other people at our table and they each shared their frustration about working in the lab with either older or younger people.

This was a real opportunity for us to share the generational strengths and differences with each of these people. The Boomers seemed to think that the Millennials didn’t have a good work ethic. The more I asked questions of those in both generational groups, the more I was able to help them to share their opinions and/or frustrations. Most importantly, I made a point of asking each person what was important to them in the workplace.

The Millennials learned that the Boomers were “bred” to work beyond the expectations of their job. Most importantly, they found their identity in their work. This is one reason the “Boomer co-worker” delayed their retirement because of the fear of losing their identity.

The Boomers learned that the Millennials had a very good work ethic, they just valued work-life balance. It was actually Generation X that introduced work life balance to the workplace and the Millennials bought into the concept. The other strength of the Millennial is their passion for finding a purpose in their job.

By the time our hour was up, you could see the difference in how they related to each other. It’s amazing what education and awareness can do for people.

As a final note, the next day we co-taught a course on Stress Management. Wouldn’t you know it, we experienced the same situation at our “Stress Management Roundtable” lunch! It was fun to see how people began to see their co-workers through a different lens.

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

Personal and Situational Variables of Leadership Development

Several aspects influence whether people learn from experiences in order to become a better leader. These variables can either be personal traits of the individual learner or situational aspects of the circumstances. Both personal and situational variables of experiential learning increase the development of leaders.

Personal Variables

Being exposed to experiences does not necessarily mean that people learn from them. There are some personal attributes necessary to foster learning from experiences in order to develop one’s leadership potential. The main variable that influences experiential learning is the capacity and practice of self-reflection. Being able to draw lessons from experiences is indeed what drives leadership development and self-reflection increases the number of lessons noticed in each experience. Furthermore, experiences that are challenging promote learning. How challenging an experience is can be seen as situational, however it is also personal as some people are more drawn to challenging experiences than others. Additionally, motivation to learn increases experiential leadership development. Whether the learning is motivated through goals, actions, or to simply seek knowledge, motivation influences leadership development.

In addition to being reflective, motivated, and challenged, experiential learners also need to think and act. Thinking is important because it allows the learning to plan and strategize. Finally, acting is one of the most critical aspects of learning, because it closes the cycle of learning and creates the next cycle of experiential learning.

Furthermore, assessments bring a deep level of self-awareness about their behavioral and thinking patterns, behaviors, and preferences. Knowing what one does well, where one can improve, and where the developmental gaps are is essential for leadership development. The experience with assessment is both a personal and situational variable, because how people are rated or rate themselves depends on the situation and on the personality of the person being rated. Finally, vicarious learning is learning through other people’s experiences. However, not everyone who witness other people’s leadership challenges, solutions, and behaviors develop their own leadership skills. Therefore, this is both a situational and personal variable as a person needs to be motivated to learn but also needs access to a vicarious learning opportunity.

Situational Variables

Some of the factors that influence learning from experiences are situational. This means that people have to be in a specific type of situation in order to not merely experience something but to increase their leadership effectiveness based on that experience. Experiences in themselves are situational; for the most part one cannot make certain experiences happen but they happen to people instead. However, there are three specific aspects of employment that people can seek that foster situational learning opportunities. The first one is getting a new job, changing job status, or job location. There is a tremendous amount of experiential learning that takes place when one of these aspects of a current job changes. The second is a change in task-related characteristics, such as a process or systems change. Thirdly, obstacles increase learning. Such obstacles can be difficult supervisors or employees, another company launching a similar program, or a crisis. All these experiences promote learning because jobs are central in leadership development, as well as, different assignments and experience with obstacles.

Support is an additional situational variable that increases learning. Support promotes learning because it makes people feel reassured and safe. Feeling safe also increases learners’ motivation, competency, and self-efficacy, which all promotes learning. Additionally narrative accounts shared by leaders and the organization promotes learning from experience, even if the narratives are fictional. Hearing stories about effective and ineffective leadership increases listeners’ own leadership skills through cognitive elaboration and transportation. Finally, allowing people to experience the consequences of decisions increases their learning and develop their leadership potential. Experiencing the consequences will increase people’s understanding of the impact of decisions and how departments and tasks are interconnected.

People learn in many different ways, but we all go through experiences, whether they happen to people directly, through vicarious learning, or through narratives. The better leaders can maximize learning from experiences, the more prepared the next generation of leaders will be to tackle challenges, dilemmas, and problems.

 

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

Meaningful Metrics

Performance improvement (PI) metrics are a great way to assess the overall quality of your laboratory program. They allow you to track vital data related to CMS outcome measures, which can directly impact the financial well being of your organization. However, labs should be careful when choosing which metrics to monitor, and should routinely evaluate if the metrics they’re using are still meaningful to them.

Even a small laboratory will generate a ton of data throughout the year. The key questions to ask yourself are: 1) What do I want to know? 2) What will I do about it once I have the answer?

There may be different sets of metrics that laboratories will have to monitor and report, depending upon who the target audience of the final data analysis will be. Metrics and reports can be generated for your patients/customers, internal laboratory staff, management, and senior leadership. You may also be called upon to share your metrics with regulatory agencies as well to prove the effectiveness of your quality assurance program.

Ensure your reports are relevant and meaningful to the audience they are being shared with. Customer/Patient centered metrics can include items such as satisfaction survey results, average waiting time for outpatient blood drawing locations, and average cost/revenue per test. Internal laboratory staff metrics can include turnaround time reports for STAT tests, compliance with critical call notifications to providers, and percent completion for required monthly maintenance tasks. Higher level metrics that can be reported to management and administration may include performance on proficiency testing surveys, regulatory inspection results, and percent of corrected reports that were issued.

If goals have been met and sustained consistently, consider raising the bar and challenging yourself even further. Each metric should have 3 goals: 1) Minimum Threshold (must be achieved each review period), 2) Annual Goal (desired overall goal to account for monthly fluctuations in the data), 3) Stretch Goal (motivational tool, achievable but not guaranteed a high rate of success). Increase your minimum threshold limits to be closer to your stretch goals, and see what your particular organization can realistically meet and sustain. Be careful to not set unrealistic expectations, as this can lower morale and result in misleading interpretations of the data. Work with your clinicians and regulatory agencies to determine appropriate, and realistic goals, and utilize national benchmark standards when available.

Metrics that were added to address and monitor a specific known issue or problem should be evaluated for necessity once the issue is corrected. Consider reducing the monitoring of these items from monthly down to quarterly, semi-annually, or annually until you have confidence that it no longer requires monitoring.

When issues are identified, a root cause investigation should be performed with the intent of identifying the true cause of the problem – not to point blame to a particular person. The depth and intensity of your investigation will depend upon the specific metric which failed to meet its goal.

Properly identify the problem. To learn from our mistakes, we must first properly identify them. What may seem like an obvious root cause, may not be the real reason for an issue. For example, turnaround time metrics – if you did not complete STAT troponin tests in <45 minutes, simply purchase a new instrument that is faster. Well, it’s not quite that simple.

Break it down further into pre-analytic, analytic, and post-analytic times. Is the bulk of your 45 minute window taken up in the pre-analytic phase? Are samples being held in a central receiving area for 20 minutes and batched before being brought to the chemistry department? Are you testing serum (which needs to first clot before being spun) or plasma (which can be spun down immediately)? Is there a delay in verifying/releasing results into your LIS where autoverification would improve this process?

Before attributing instrument downtime as a cause, confirm that the outliers were in fact during the time period when the instrument was down. There’s a higher chance you have a pattern of poor TAT performance around change of shifts or meal breaks, than during a 6hr downtime on a single day in the month. Also look at how you are analyzing your metrics to ensure they are accurate. Are you including add-on tests based on their original received time, or based on when the troponin was added to the original order?

Develop a corrective action/preventive action plan. Based on what you identified to be the true root cause(s) that contributed to poor PI metrics, develop a plan for addressing these weaknesses. Identify who specifically will be responsible for performing each step in the action plan, and who will be held accountable for ensuring it was performed.

Implement the plan(s). Document the date the corrections were fully implemented, along with any delays or obstacles encountered.

Collect and analyze more data. Depending on the severity of the failed metric, you may want to begin analyzing the effectiveness of your improvement plan immediately. If there was a spike in the number of employee safety incidents reported last month due to ongoing construction in a department, the work conditions should be monitored daily/weekly for improvements.

Conversely, looking at data too soon may not paint an accurate picture of the true effectiveness of your corrective actions. Some corrective action plans may require several steps or phases for full implementation. For example, a process change will require an update to your procedure manual, retraining of all staff, and then rolling out the new process. This may take several days-weeks before 100% implemented and improvements can be detected.

Monitor the results. Check for sustainability of your corrections – staff may be on their best behavior the first week after being spoken to, but can return to old habits after that. They may not fully understand that although one process is easier for them, it is adversely affecting the overall performance of the entire lab team.

If you are consistently struggling to meet your metrics, consider looking for ways to implement lean process changes. Upgrading to a STAT spin centrifuge may save you 5 minutes on the pre-analytical side; but you may still have room for improvement. Do you consistently receive 20 samples at a time, meanwhile your centrifuge will only hold 8 tubes? Do you receive tubes of different sizes (adult vs pediatric), and is your centrifuge capable of quickly and easily interchanging inserts to accommodate both types?

Ultimately, be sure to engage your frontline staff and listen to their opinions on what is working, and what could be improved upon. They are the ones doing the tasks day in/day out, and are your subject experts on where some of the shortfalls may lie. Even if the answer is simply not having enough staff available, having detailed analytical metrics can help management justify the cost of adding additional team members, and also pinpoint the exact days and times where the help is needed most.

Bio

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

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

Albumin Values in Transgender Men and Women

This month our study results were published in a special edition of Clinical Chemistry describing how laboratory values in transgender men and women when taking hormone therapy. While retrospective, we hope that this information will help improve transgender medicine.

There were many interesting results found in the study and I hope to describe bits of them in greater detail each month.

We wondered what we might find if we took a broad, unbiased approach comparing all laboratory parameters commonly measured by physicians. Just because there are no sex-specific differences in analytes, changes could still occur secondary to exogenous hormone use.

Albumin, which is the principle protein in our blood, was found to be decreased in transgender women after taking at least 6 months of estradiol therapy (p<0.0001)1. This was unexpected, because one reference range for albumin is used for cisgender males and females.

Frequently, changes in lab values move in opposite directions for transgender patients taking estradiol vs. testosterone (ex. hemoglobin goes up with testosterone and down with estradiol). We wondered if a similar opposite change might occur in albumin for transgender men taking testosterone. However, there was no change in albumin levels from baseline for transgender men.

The cause of decreased albumin was not readily available, but several factors could be influential. Albumin levels reflect the long term nutritional status of a patient as it has a long half life for turnover (t½= 3-4 weeks). Thus, the change in albumin could reflect a dietary change in transgender women. However, in the chart review there was nothing to suggest a substantial change in diet. While several of the patients would go on diets and lose weight, the weight loss was (unfortunately) often short lived (< 1 year). Looking towards a more objective reflection of dietary changes, the body mass index was nearly the same for transgender women pre-hormone therapy vs. while on hormone therapy (BMI: 27 vs 29, p>0.05).

Some studies have shown an increased prevalence of disordered eating behaviors among transgender individuals2, which could affect overall nutritional status as reflected in albumin. However, this should be controlled for by the control group, which is just transgender patients who haven’t taken hormones previously. 

Another consideration is that body composition changes in transgender patients such that transgender women lose lean mass and have an increase in body fat percent3. Although this could affect the metabolic profile (which it didn’t in our study), changes in fat percent don’t explain altered albumin levels.

Albumin levels are also low in patients with chronic liver disease, but this would be inconsistent with the patients’ medical history or other lab results. Frank nephrotic syndrome is unlikely as there were no reports of this disease within our population, but we did not have data on urinalysis, so we can’t say for certain.

One study did show that males (TW baseline equivalent) have higher albumin than females at younger ages (<60 y.o.) that equilibrates in later decades4. This sex-specific difference shows how estradiol decreases albumin to cisgender female levels. However, the reverse effect (increased albumin) does not occur with testosterone in transgender males. This demonstrates how sex-specific reference intervals cannot be simply reversed for transgender patients.

In a normal set of outpatients in the UK, oral contraception use (which includes estradiol) in women decreased their albumin levels by 0.2 g/dL, which is a smaller magnitude than found in our study, but supports a hormonal basis for sex-specific differences in albumin4.

Although the decrease in albumin for our cohort was not clinically significant (did not pass lower limit of normal albumin reference interval), it would be important to monitor albumin levels in older or elderly transgender females on hormone therapy. Elderly patients are at increased risk of hypoalbuminemia, especially when hospitalized5.

Summary:

  1. Albumin is decreased in transgender women taking estradiol therapy.
  2. Albumin levels do not fall below normal ranges.
  3. This could be more important in older or elderly transgender patients who are already at risk of hypoalbuminemia.

References

  1. SoRelle JA, Jiao R, Gao E et al. Impact of Hormone Therapy on Laboratory Values in Transgender Patients. Clin Chem. 2019; 65(1): 170-179.
  2. Diemer EW, Grant JD, Munn-Chernoff MA et al. Gender Identity, Sexual Orientation, and Eating-Related Pathology in a National Sample of College Students. J Adolesc Health. 2015; 57(2):144-9.
  3. Auer MK, Cecil A, Roepke Y et al. 12-months metabolic changes among gender dysphoric individuals under cross-sex hormone treatment: a targeted metabolomics study. Sci Rep. 2016; 6: 37005.
  4. Weaving G, Batstone GF, Jones RG. Age and sex variation in serum albumin concentration: an observational study. Annals of Clinical Biochemistry 2016, Vol. 53(1) 106–111.
  5. Cabrerizo S, Cuadras D, Gomez-Busto F et al. Serum albumin and health in older people: Review and meta analysis. Maturitas. 2015; 81(1):17-27.

-Jeff SoRelle, MD is a Molecular Genetic Pathology fellow at the University of Texas Southwestern Medical Center in Dallas, TX. His clinical research interests include understanding how the lab intersects with transgender healthcare and advancing quality in molecular diagnostics.