Written By: Calvin Ball, MS, MLS(ASCP)CM, CMQ/OE(ASQ), CLS
You would be hard-pressed to have gone through medical laboratory scientist training and worked in a clinical laboratory to have not heard of Lucia Berte. Lucia has written several textbooks, many articles, and been the main presenter in numerous webinars. In her repertoire, she was one of the few people to have been involved with laboratory quality from the beginning. Lucia has progressed through every level of the clinical laboratory. She started her career as a blood bank medical laboratory scientist, became a blood bank supervisor, blood bank specialist, special projects coordinator, blood bank technical director, laboratory quality assurance director, and then a consultant. She has served on many committees and work groups, most notably for the Clinical Laboratory Standards Institute (CLSI) and the International Organization for Standards (ISO), where she was involved with others in crafting consensus standards and guidelines to advance quality initiatives within the laboratory field.
I had the opportunity to interview her via telephone to gain insights into how she became involved in quality management and to obtain her thoughts on the current state of quality in the laboratory community today. Lucia provided so much information that we decided to publish the interview in a two-part series, where Part I focuses on the history of quality in the clinical laboratory and Part II looks at the present state of quality in the clinical laboratory. Lucia has a wealth of knowledge and provided some thought-provoking insights. We performed some light editing, because we wanted our readers to be able to gain some fascinating knowledge about laboratory quality.
Can you provide some details about your experience as a laboratorian?
I spent the first 20 years of my career working in blood centers and medical laboratories, and towards the end of that 20 years I was the laboratory’s quality coordinator in addition to being the blood bank manager. In the second half of my career, which is now about 22 years, I have been a consultant and trainer for blood centers and medical laboratories in the U.S. and in other places in the world, teaching them about the quality management system (QMS) elements of document control, training, competence assessment, equipment management, nonconforming event reporting, internal auditing, and continual improvement.
At what point in your career did you become interested in quality management and quality?
In the mid-1980s the U.S. Government’s Medicare and Medicaid system implemented Diagnosis Related Groups, called DRGs. What that meant was, for Medicare patients, the government was only going to pay, a certain amount of money for a given diagnosis code. That caused hospitals to look at what they were spending on patients in that certain diagnosis code and try to make their operations more efficient. A lot of that included looking at laboratory testing and deciding what was truly necessary versus unnecessary.
Around that time in the blood bank environment, HIV started to appear and started to be a concern in the blood supply, so the Food and Drug Administration (FDA) wanted blood banks not only to test for HIV, but also ask questions of donors about their potential exposures to HIV. Then in the early 1990s, the FDA started requiring good manufacturing practice (GMP) for the blood center environment. GMP is a regulatory requirement for drug manufacturers and the FDA classifies blood as a drug. Therefore, GMP was being applied by the FDA to blood centers, which didn’t really have a very good idea of what it was and how it worked.
The American Red Cross (ARC), the American Association of Blood Banks (AABB), and the Council of Community Blood Centers held many workshops trying to learn about GMPs, articulate it in blood bank language, and put it into some kind of plan that blood banks could follow, which is really just another way of saying quality management of manufacturing practice. I was starting to get involved through AABB and it just really clicked with me that an organized approach was needed for any kind of management of blood centers, medical laboratories, transfusion services, anatomic pathology, cytopathology, and in any kind of laboratory anywhere in the world.
Having the plans for how to manage the administrative aspects of a laboratory was as critically important as having technical procedures for how to run instruments and do manual testing. By having only technical standard operating procedures we were only looking at half of laboratory quality. The other half was getting the administrative part of management to get their act together so that the laboratory’s medical directorship and administrative management was also following a plan for quality, just like testing follows QC plans. That all really resonated with me, and I wanted to be involved in developing that kind of plan and then teaching it to people. Que the AABB’s quality committee. We first had a blood center quality committee and then we had a hospital medical laboratory transfusion service quality committee. I started getting really involved with those.
Then because of all that quality management plan stuff being implemented in blood banks as a result of the FDA demanding it, all of those concepts were equally applicable to clinical laboratories of any type, size, or scope. The Clinical Laboratory Improvement Act (CLIA) was released in 1988 for implementation by the end of 1992. CLIA itself is not a QMS, but has QMS elements. The challenge became how to align those two things, and it was actually pretty simple to align CLIA with a QMS. We identified a lot of gaps in the clinical laboratory CLIA approach as opposed to the FDA mandated QMS approach for blood centers and transfusion services.
CLSI became involved because they write guidance for medical laboratories. I started getting involved in helping to draft those kinds of documents, volunteering to help develop a quality management approach and a plan for how to implement QMS in medical laboratory environments. You can see from the mid ’80s to now that’s about 30 years or so that I’ve been involved, starting with baby steps and then just developing my whole career into helping develop these plans as a volunteer, and then teaching them as part of my business.
It sounds like you were in the right place at the right time.
I look back on it and think that I have been blessed and fortunate in having opportunities presented to me, and even though they were scary, it was a chance to grow and, smart or not, consciously or not, I thought, “Oh, that sounds interesting. Why don’t I give this a try and see what happens?” So yes, perhaps I was in the right place at the right time but I think, collectively, with your education, experience, and interests, the universe is cool; it kind of prepares you for what crosses your path. Then you have to decide where you want to go with that. I could easily have said no, because those opportunities would have been scary, to do something that hasn’t been done before, or to be in the spotlight. Like give a talk about something that you only are just starting to learn, but I think that’s what makes us grow, so I guess I’m kind of glad I just said yes to a lot of opportunities.
One thing I’ve always lived my life by, and I heard this a long time ago, is that luck is opportunity for the prepared.
That is, I think, an ancient Chinese proverb. That luck is, yeah, being prepared for what crosses your path and then choosing to do it. You know? To be fearless. To go where you haven’t gone before. What do they call it? Have a stretch goal, to challenge yourself. Otherwise, it’s the same old, same old.
I was wondering, because when you were talking about your background and how you were involved in quality in the lab, basically almost from the beginning, I was curious as to how much opposition you received when you were trying to make that change, or trying to enact change?
Good question. A lot. With the rise of HIV, the blood centers argued that they were a service organization, they provided blood components as a medical service to patients, and the FDA said, “No, we say blood is a drug. We are the FDA. We give you licenses to collect blood, and prepare blood components, all of which are drugs. You either follow the good manufacturing practice, or we will yank your license and put you out of business.” It was that simple.
Although there was a lot of pushback in editorials and articles, in the end the blood centers realized that the GMPs were really nothing more than some of the same processes that were already being followed to some extent, but needed to be more formalized, more documented, and with more documented follow-ups, so they finally came around. Another big pushback I had was trying to convince laboratories that, when I say quality system essential (QSE), are you familiar with what I’m talking about, the 12 QSEs?
Okay. Well, so the second big pushback I got was when medical labs said the 12 QSEs didn’t apply to them, because it was only about blood banks and transfusion services and all they needed to have was CLIA. What was really important and interesting at the time, now I’m speaking about the mid to late 1990s, 20 years ago, the College of American Pathologists (CAP) said the same thing. “This is the United States; we only have to comply with CLIA. Why would we want to do anything else?” We tried to show them that everything that was in their checklists fell into each of the 12 QSEs, but that there were gaps compared to what was going on with good manufacturing practice, and what was going on with the AABB.
If there was a requirement to have a nonconforming event management program in blood banking that recorded things that went wrong so they could be investigated to find the root cause and remove it, why wouldn’t we want to do that for the rest of the lab? I was getting a lot of pushback about that. Like I said, it was the early adopter labs that had people who got it, that said, “You know what, you’re right. We’re losing a lot of money through nonconforming events. Our customers are unhappy. How many times can we lose a report and simply reprint it and send it out and not know why we lost the report?” The early adopter labs, some of my early clients in the late ’90s and early 2000s, were some of the big hitters out there.
Some big well-known labs, regular community hospital laboratories, and multi-laboratory hospital systems got it. Some medical center labs said, “Yeah, this is going to work for us, and it’s going to solve a lot of our problems.” Then what we tried to do was encourage those laboratories to do posters, papers, and audio conferences. There’s theory and application. I taught theory, and I explained the theory and how to implement it, but the application came in the lab, and I didn’t work in those labs, and I didn’t own those labs, and I didn’t manage those labs. The application had to come from the people who said, “Okay, we’re going to try this.”
We tried to get people to write about their experiences in applying the QSEs, and those papers, audio conferences, workshops, and posters, slowly came out in the last 12 to 15 years. As other labs started reading about actual experiences, they were becoming more open to the concept. The labs didn’t necessarily write about, “Here’s our quality management system,” but one paper was about an equipment management program, and tracking equipment from the time you get it, until the time it’s discontinued. Well, that’s exactly what QSE Equipment is all about, but people didn’t have to see it as QSE Equipment, they just had to see that as, “Wow, this is a pretty cool way to track and manage all of our equipment.”
The pushback has lessened over time. The biggest pushback I get now is about time and money. Quality costs us time and money. When labs ask, “How much is it going to cost us to have you come and consult with our lab?” I always say, “You’re already paying money; all the money you would be paying me you’re already paying in failure. I know where your failure is. If you want to find out where it is, you might want to be interested in learning QMS concepts.”
That kind of changes the game a little. What I can say is I experience a lot less pushback now, because we’re 30 years into QA, and a good 20 years into QMS. The people who don’t get it now, the labs that don’t get it now, are the ones that are having financial problems and suffering, and facing personnel shortages and not knowing how to add more work to the few people they still have. It can be done; it just has to be thought of in a different way.
A quick question on the inception of quality in the laboratory, or using quality management principles in the laboratory. At that point in time, in the 1980s, what was the quality community like? I mean, I know it was in its fledgling stage, but I was just curious as to who gravitated towards that challenge like you did?
In the mid-1980s the only kind of quality that existed was probably the QC that was mandated by regulatory and accreditation organizations in medical laboratories. Realize the mid-80s was before CLIA. In fact, it was quality or the lack thereof in the mid-80s that generated CLIA because laboratories were trying to focus on making money and being, what they thought, was efficient. Then, having erroneous results, cause problems in patients, but I won’t elaborate on that. In the 1980s, QC existed primarily in medical laboratories and testing because accreditation organizations like the CAP required QC because CLIA mandated it.
There weren’t a lot of other places in the hospital that were doing routine temperature checks every day and calibrating thermometers. Those kinds of things almost didn’t exist. I think there were some controls in diagnostic imaging, what we used to call X-Ray, to ensure that the imaging equipment for X-Ray was actually taking a picture of something and the resolution was good enough to read, but there wasn’t much QC going on anywhere in the hospital except, probably, the laboratory. All of that changed with the DRGs because the hospitals were focusing on caring for a patient within a certain money amount. I’ll just make this up, I’ll say open heart surgery, diagnosis code 12345, Medicare says, “Okay, if you have a Medicare patient we’re only going to give you,” I’m also making this up, “$15,000 for a triple vein bypass graft.” If it costs you more to do that for that patient, then the hospital eats the difference or you try to collect the difference from the patient him or herself, or a secondary insurance.
So hospitals started focusing on what it was costing them to do the procedures, and there was a rallying cry by the Joint Commission saying, “Stop. Stop. Stop. You can’t look just at the cost. You have to look at quality.” So the Joint Commission implemented, in the late 1980s then, what they called monitors. Every department in the hospital had to have at least two monitors; every patient care area in the hospital had to have at least two monitors. Something they were measuring that let them know how good their quality was, and that became what was called quality assurance (QA). QC is method control. It’s about the test method, you run a positive and negative control for a batch of tests and you have some assurance that the patient’s results, if the controls worked, the patient’s results are likely to be correct.
Well, QA was completely different. QA measured process output, for example, turnaround time (TAT). TAT is not QC; it has nothing to do with the method. It has to do with how much time it takes from when the laboratory receives the sample until the verified result goes out the door, and was that appropriate for patient care? Of course, in most cases, it needs to be much shorter. That was one example about QA monitors. Another really important QA monitor was the quality of the samples being received in the laboratory for testing, especially those samples collected by non-laboratorians.
Another thing that happened was that hospitals decided that it was not economically beneficial to pay a phlebotomist, a laboratory trained phlebotomist … and I’m just making this number up, let’s say $15 an hour. That cost a lot of money when they could use what they called patient care technicians (PCT), who removed bedpans, and answered patients calls, and brought them water. Teach them how to collect blood samples and send them to the laboratory and they could pay a PCT $8 an hour.
Laboratories started to lose their phlebotomy teams, and nurses started to gain PCTs, and nurses also started to gain the responsibility for collecting blood samples. Nurses don’t want to collect blood samples, and PCTs weren’t trained properly. What happened was more and more samples were coming into the laboratories that were not acceptable for testing. Smart laboratories started to figure out, “Well, this is really dumb.” Because what happens when the CBC sample is clotted and not acceptable? They call the lab and then have somebody from the lab run up and redraw the sample. What is the hospital accomplishing? Smart labs started telling their administrators, “You think you’re saving money by paying $8 an hour for a PCT? Well, look how many samples we had to recollect this month because your PCTs or the nurses didn’t collect them properly.”
That was part of QA, measuring and monitoring how well, you know, garbage in, garbage out. If the sample collected by your people is no good for testing, don’t scream at us because we’re telling you we can’t use it. That was a big, hairy quality issue in the 1990s. That whole idea of the Joint Commission requiring measuring and monitoring of non-test method processes became QA. As time went by, then into the ’90s, then I told you this whole FDA thing started evolving into not just a couple of monitors a year to make the Joint Commission happy. It’s like you should be looking at all your processes. You should have a plan to manage the quality of all your processes, not just the two you picked this year to make the Joint Commission happy. All that was all playing together in the 1990s and the early 2000s. In the ’80s through ’95 I was in the hospital environment, and then beginning of ’96 I became a trainer and a consultant in quality management because we really needed it, really badly.
The progression that happened was QC, then QA, then QMS. And QC, which we thought was all of quality is really only a small part of quality, it measures test methods in the examination phase of testing. QA asks you to look at processes other than QC. I gave you two: sample acceptability and TAT. Here was another one nobody thought to measure and monitor. How many times did a report go out the door, and it had a mistake on it and had to be called back and corrected in the computer or on a paper report? No laboratory was routinely measuring how many corrections it made every month or every year. That was another QA monitor. That measured the post-analytic processes. If the laboratory’s product is data and information, how good is your product if you send out reports that have a misdiagnosis, or typos, or wrong results, or switched results on them?
That was an eye opener for labs. Like, “Wow, we never thought about that,” or, “We should have been thinking about it all along and now you really need to think about it because patients are being hurt.” QA went beyond the examination/analytic part of the laboratory to the pre-analytic and post-analytic parts of the lab. Then QMS asks a different question, for example “If we have QC for testing and two ways for pre-analytic and post-analytic processes what do we have to measure and monitor and to plan for quality in the administrative aspect of the lab?” An equipment management plan, each piece of equipment in the lab has a birth and a death. That entire existence of that analyzer, or centrifuge, or refrigerator, or freezer should be tracked throughout its lifetime. When did it come in? How is it calibrated? How is it maintained and calibration verified across time? What kind of service and repair records and when did we decommission the piece of equipment and sell it, or get rid of it, or give it to another lab? Or whatever its final disposition was, birth to death. It’s the same for people.
When CLIA came out in ’92 and required competence assessment, people went berserk because they didn’t know what that meant. Then we needed a plan for how to properly assess the competence of people. Experience is not competence. You see how all these things start to fold in? And competence assessment is a process that has nothing to do with QC, or sample accessibility, or report accuracy. Competence assessment is a management process to verify that people know how to do their work and are doing it correctly. The same with document management. It’s the management process to ensure people have the correct instructions at all times. Nonconforming event management, when things go wrong they need to be reported because each thing that goes wrong represents a process that is not working properly. It will keep not working properly until we identify these problems and do root cause analysis on these problems.
All of those kinds of things: proficiency testing, laboratory inspections, training, competence assessment, document management, nonconforming event management, continual improvement, those are all management processes. That’s how quality systems came into play. We had to add to the technical laboratory the administrative management because if there is no equipment management plan, equipment will break down and we can’t turn out the best results.
Yes, that’s true.
The progression is QC, QA, and QMS. Quality management is required by CLIA. We need to live in QMS for a laboratory to be successful at caring for our patients. Any laboratory that’s not doing that is really not getting it. They’re not getting the fact that technical and management processes need to be working properly.
Yeah. That’s true.
Yeah, you’re right. I sound like a preacher.
No. No, no. I really appreciate it.
Well, Calvin, I’ve been called Sister Lucy the quality evangelist. Probably not kindly either.
Yeah, I’m used to getting flak for being too vehement about this. After all these years, there are still some labs that just don’t get it because they’re focusing on money. And they’re focused on reducing full-time employees (FTEs) instead of improving their processes to live with the FTEs they have.
Lucia Berte is currently President of Laboratories Made Better! P.C., a laboratory consulting firm that focuses on process management. She can be contacted at lmberte@LaboratoriesMadeBetter.com.