Reference Intervals vs. Reference Change Values

If we didn’t use reference intervals (RI), how would we know whether a person is “normal” or not? Or more accurately, how would we know whether a lab test result indicated health or disease? Reference intervals have been around as long as lab tests and they help clinicians diagnose and monitor a patient’s disease state. .

Most RI are developed using a specific patient population and should be used only with that population. However, some RIs are “health-based,” such as cholesterol and vitamin D. Both these analytes have RI that indicate what amount of the analyte should be present in a healthy individual, not how much is present in your specific population of patients. In general, health-based RI can be utilized in all populations, as long as the analyte assays are commutable. Thus these type of RI are often more useful than population-based intervals.

But should we be using reference intervals at all? One problem with population-based RI is that any given individual’s values may span a range that covers only part of the population RI due to biological variability. For example, an individual’s creatinine may be 0.6 – 0.9 mg/dL regularly. Since the RI for creatinine for his population is 0.4 – 1.4 mg/dL, a value of 1.2 mg/dL would not be flagged as be abnormal. However, 1.2 mg/dL may very well be an abnormal result for this individual We need to consider using reference change values (RCV) in addition to RI.

Reference change values are calculated values that are used to assess the significance of the difference between two measurements. Essentially, a RCV is the difference that must be exceeded between two sequential results for a change to be a significant change. The calculation requires knowledge of the imprecision of the analyte assay (CVA) and the biological variation (CVI) of the analyte. The formula for calculating RCV is: RCV=21/2 · Z · (CVA2 + CVI2)1/2 , where Z is the number of standard deviations for a given probability. Luckily, labs know the imprecision of their assays and there are tables available for biological variation.

It’s very likely that neither RI nor RCV by itself is adequate for interpreting analyte results. Using both may be a better alternative, especially using RCV for monitoring disease progression or therapeutic efficacy. Flagging sequential values that exceed the RCV—and reporting this change—should be considered.

-Patti Jones

Decisions, Decisions–Part 1

I’ve been reading a book called Leadership and Medicine by Floyd D. Loop. In it, he writes about decision making and its importance in leadership in all industries. In laboratory medicine, choices must be made quick and definitively. This skill can be observed early in a technologist’s career, often even as they train during their clinical rotations. As leaders we can pinpoint the quick thinkers and those who will have what it takes to make the larger decisions once they become leaders themselves. As leaders our decisions have more impact as we work our way up the ladder until the decisions we make affect entire organizations. Decision making at the executive level can be daunting and seal your fate as a success or the figurehead to blame.

The most important decision a leader can make is choosing their team members. Selecting a team that is similar to you may not always be the smartest decision. If you surround yourself with likeminded people, you will miss information and make ill-informed decisions. Contrary thinking will bring different sides of an issue to light. It can be hard to interview—let alone hire–someone you know doesn’t think like you, but their alternative view could strengthen your team. When I interview for leadership positions one of my first questions is, “Is this your first round of candidates or have you passed on any candidates?” If they have re-posted or passed on candidates they are not afraid to wait to find a person who fits their needs.

Most people make lists for projects that need completed. Ever write down a list of decisions that need to be made and their deadline? Former CEO of The Cleveland Clinic Dr. Loop writes, “Some leaders believe that all decisions must be grand in scope. The facts are that most decision making involves small details that add up to a larger goal.”

All of these decisions are null without one thing, trust. Trust in yourself as a leader as well as trust that you are a good decision maker from the people you lead. Decision making is at the heart of any organization and as leaders we must look for team members that can complement our weaknesses and build trust as we lead. With those two in hand you will find yourself making better decisions.

-Matthew Herasuta

Do You Know How to Build a High-Performance Team?

How successful have you been in your hiring high performers? That’s a question that opened an excellent session today at ASCP’s 2013 Annual Meeting entitled “Mis-Hires: How to Avoid Making One and How to Avoid Being One.” Lewis Hassell,MD, Director of Anatomic Pathology in the Department of Pathology at the University of Oklahoma Health Sciences Center and a faculty member of ASCP’s Lab Management University, described the “ABC” ranking of employees.

At one end of the spectrum are “C” employees, those that make managers happy when they join someone else’s team, said Hassell. The “A” employees are the ones that always come through for you—the ones mangers want to hire.

“B” employees are in the middle, but in the right environment, said, Hassell, these can become “A’s.”

On average, managers succeed in finding “A” level employees about 40–60% of the time, but studies show that managers can boost that rate to over 90%. How? By altering their hiring practices.

The usual approach—screening CV’s and inviting promising candidates in to interview—favors candidates that make a strong first impression. Job seekers can game this system; they can pad resumes and produce answers they think hiring managers want to hear. This approach, said Hassell, values a candidate’s affability and availability over attitudes and abilities.

On average, managers succeed in finding “A” level employees about 40–60% of the time, but studies show that managers can boost that rate to over 90%. How? By altering their hiring practices.

Managers might gain more insight into a candidate’s judgment, integrity, and passion, he said, by presenting the job candidate with a scenario. Ask candidates about a challenge they encountered in a previous position and how they responded, suggested Hassell. “Candidates who can’t think of a challenge probably aren’t ‘A’ level,” he said. Don’t overlook red flags, he said, or even pink ones. Don’t readily dismiss eccentricities, try not to hire out of desperation, and don’t choose a candidate merely because they’re better than the last person who held the job, he cautioned.

Job seekers can also maximize their career success by carefully assessing the quality of the organization they’re about to join, not just the location or the financial remuneration. Hassell admonished job seekers to do their due diligence in order to join an organization that will enable them to function at an “A” level.

Students of Lab Management University who could not attend this session in person can see a recorded version of it in October at Lab Management University. I encourage job seekers and hiring managers alike to watch it.

-Michelle Hoffman, Director, ASCP Publications

Bump in the Night

When is the last time you spent the night in your lab on the 3rd shift–a month, year… maybe a decade? How many supervisors/managers know exactly what happens on their off shifts? I bring this up because most hospitals require certain staffing levels even if they only see 15-20 labs from ER a night. If this is the case in your facility, you’ve been provided with an excellent opportunity to empower your employees while “doing more with less.” Those duties that are essential but not time sensitive—such as analyzer maintenance, quality control, and batch testing—are well-suited for off shift employees. All it takes is a bit of creative thinking.

When I first started working in my current position, the blood bank was prototypical. We ran all QC on first shift, performed morning duties, and tried to process as many pre-admission testing (PAT surgery) specimens as we could with inpatient specimens mixed in. Second shift was responsible for PAT tests and routine in-patent specimens.  With productivity measures putting pressure on staffing, I thought about how I could rotate duties to allow one of the three 2nd shift technologists to leave early and only work a half shift. First, I made 1st shift responsible for all PAT testing. Second shift was to pour off the Types and Screens and first shift would do them in the morning. Second, to account for the increased workload created on first shift I made the second shift responsible for tube-testing QC and 3rd shift responsible for Gel testing QC. When things quieted down in the evening one technologist could leave.

This is just one way to look at your daily operations and think what could be done to increase productivity. This rotation of duties required a few things.  First I had to teach the off-shifts how to do the QC. This was not a challenge because they were excited to learn something new. Next I had to assure first shift that the other shifts were able to perform these new duties. This aspect was the most difficult even if it meant making their jobs a little easier! Finally, I needed to monitor the workflow to make sure that this change was effective and helped with productivity, which it did.

Working the occasional off-shift has given me insight into what actually goes on in our lab. It is important as managers/supervisors to know the workflow of your lab 24/7. Working a 2nd or 3rd shift is also an opportunity to connect with staff that for the most part you may only see during a shift change. I would encourage all supervisor/managers to be aware of workflow not just during the 8-12 hours you work but for the entire time your lab processes specimens. Try to spend some time on an off shift and see what really goes bump in the night!

-Matthew Herasuta

Tough Conversations

Leadership involves all the difficult situations that most people tend to avoid. However, as leaders it is our responsibility to take those difficult situations and turn them into constructive encounters. No one enjoys telling an employee that their performance is subpar but there are productive ways to have  this discussion. A Performance Improvement Plan (PIP) is one of the tools I use to identify the specific areas that an employee is struggling, identify the tools they need to improve, and give them a timeline to achieve success. It’s important note that these discussions do not have to be technical in nature. PIP’s are also used for behavioral issues such as conduct detrimental to work environment.

A Performance Improvement Plan (PIP) is one of the tools I use to identify the specific areas that an employee is struggling, identify the tools they need to improve, and give them a timeline to achieve success.

I begin by identifying the job tasks that are not being performed at the expected level of competency. The key here is identifying specific job tasks that the employee can work on. For example, let’s say when John Doe works in Hematology, stat turnaround times aren’t met. When meeting with John, don’t say something like “you need to be better at hematology.” Instead, say “I need you to work on completing stat samples within the turnaround time. How can we make that happen?” Listing generalized deficiencies doesn’t give the employee a real sense of what they need to work on.

Second, clearly identify the expected improvement that the employee needs to achieve. Using our example above, we would tell John that we expect stat turnaround times for CBCs with differentials need to be less than 60 minutes when he is working in Hematology.

The last step is to determine a fair time frame to give the employee a fair chance to succeed. For our example we may monitor John’s stat CBC turnaround times for 30 days. At the end the PIP is evaluated to determine  whether or not the employee has met their stated plan. If the answer is no, you need to have a serious discussion with the employee. You may find yourself asking him if he might be successful outside of your laboratory. As leaders we must be willing to have those tough conversations. In the long run, however, a 30 day performance improvement plan is much more efficient than three to six months of training a new employee.

-Matthew Herasuta

Who Regulates Laboratory Developed Tests?

A laboratory developed test (LDT) is any test that has been developed by an individual laboratory, often using instruments and/or reagents that have not been approved by the FDA for use as/in an in vitro diagnostic test. For example, measuring pH using a pH meter and pH calibrators from a scientific supply company is an LDT. So is performing a spun hematocrit,  measuring acylcarnitines by tandem mass spectrometry, or performing newborn screening on dried blood spots. Even using an FDA-approved assay for samples or in a manner not specified by the manufacturer makes that assay an LDT. If you look around your lab, you may find that you’re performing an LDT without really thinking about it.

Who regulates these tests? The FDA regulates in vitro diagnostic testing, and LDTs fall under their purview. Until recently the FDA has used “enforcement discretion” and has essentially allowed CLIA regulations and CLIA oversight to ensure proper validation and monitoring of LDTs. CLIA regulation Subpart K, Section 493.1253 gives the specific parameters that must be properly validated in any non-FDA-approved assay. CLIA also regulates the proper usage and control of LDTs, just like any test performed in the laboratory. Is it necessary for LDTs to be regulated more highly than this?

In June of 2010 the FDA announced its intention of taking a more active role in LDT regulation in the future. They also held a public meeting to discuss their increased oversight. All laboratories which perform LDTs will do well to monitor developments in this newly intended enforcement of the FDA’s role, and keep abreast of changes coming out in the regulatory environment for these tests.

-Patti Jones

The Leadership Tightrope

When a physician describes what they do they will often say, “I practice medicine.” The reason for this is because each patient, even if they are in similar disease states, usually requires a somewhat unique treatment regimen.  The same can be said of leadership. We as leaders are constantly refining our leadership styles, and to a degree practicing what we learn and observe. Just like the patients, each employee we lead is slightly different and it is up to us to adjust to them and not vice-versa. I have been a leader for three short years but my leadership style has already gone through many changes and modifications as I learn and interact with my employees.

I have also been confronted with the challenge of the leader versus manager mentality. The natural tendency when an employee is struggling is to jump in and save the day. However, did you really help them? Perhaps the better approach is to discuss the problem with the employee, give them the tools they need, whether it be knowledge or physical items, and then observe the employee working out the problem themselves. This is the tightrope leaders walk, and it can sometimes feel like the most daunting of tasks.

I start this blog with the hopes of putting together the leadership puzzle by first analyzing the pieces and then taking a step back and viewing the big picture. I just finished my 6th year as a laboratory professional and celebrated by re-certifying with ASCP. I gain my experience through being a blood bank supervisor as well as a general supervisor in a mid-sized community hospital that is part of the larger conglomerate Cleveland Clinic. Working here has given me insight into the entire gambit of the lab as well as how we interact with the rest of the medical profession. I will often refer back to issues and how they relate “outside the four walls.” This is especially important to leadership and how we keep our employees engaged.

-Matthew Herasuta