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Our ISO Journey - and the Consequences to our Operation

Overview

The speaker will present the journey to seek ISO-level accreditation by a high complexity laboratory. He will illustrate the choices made and the lessons learned– taking what may be seemingly escalating costs and challenges, and turning them into solutions with much organizational and corporate benefit.

Learning Objectives:

  1. Illustrate how the challenge of a much higher quality system might challenge an organization to adapt to the new system.
  2. Illustrate how some of the ISO level quality system actually precipitated considerable organizational efficiency and cost savings.
  3. Provide a probable roadmap and innovative for other organizations to deploy in their own institutions.

Webinar Transcription

MR. STEVEN OLSEN:

Today I'm going to give you an overview of our ISO 15189 accreditation experience, in implementing ISO-level quality system. I'll tell you about our motivations for obtaining the accreditation and provide examples of some implementation challenges that we faced and our solutions to those challenges, as well as accreditation benefits that we have experienced so far.

MPLN is a small privately owned pathology and molecular lab with about 90 full-time employees. Our laboratory is located at the foothills of the Smokey Mountains in Merrillville Tennessee, with satellite location in Richmond, Virginia, which performs flow testing. As of early this year we have also established a footprint in the United Kingdom in Manchester.

MPLN was founded in 1989 and is a CLIA high complexity certified CAP and New York State-accredited anatomic pathology and molecular diagnostics laboratory. We perform testing in the areas of Women's Health, cytogenetics, molecular oncology, flow cytometry, anatomic pathology and genomics which is our next-generation sequencing division. We support clientele nationwide predominantly regional hospital and hospital systems, pathology practices, oncology practices, cytology and other reference laboratories. In 2007 MPLN formed Geneuity, a dedicated clinical trials division of MPLN that participates in clinical trial testing globally, and that division is our fastest growing division growing over 30 % in 2016. July of 2015 we became the sixth lab and only the second genetics lab in the US. To obtain ISO accreditation. Currently we are one of only 8 labs that hold that accreditation.

Why did we decide to become an ISO 15189 accredited laboratory through A2LA?

A2LA, by the way, is American Association for laboratory Accreditation. Well, first MPLN is a quality-driven organization, we are always looking for ways to improve our processes to pursue higher standards and ultimately provide to better patient care. As early as 2012 research organizations were inquiring more frequently about our intentions to pursue ISO accreditation and at that point it appears that accreditation is becoming an expectation for laboratories performing clinical trial testing in the United States and globally. Third, by obtaining the ISO 15189 accreditation MPLN would be able to position itself at a higher level than other competitive laboratories and additionally A2LA is independently accredited and internationally recognized by ILAC. CAP 15189 is only recognized in the U.S. and Canada. Independent accreditation ensures a hierarchy of accountability which promotes a higher level of quality and an internal … an international recognition allows data and results to be more readily accepted in overseas markets. And that was very important to us because we were already seeking overseas expansion.

Timeline

Let's get into the timeline a little bit of how this came about. In May of 2014 we initiated the application process with A2LA, and received a copy of the ISO 15189 regulation. For the next 5 months we performed a rigorous internal gap analysis during which we compared our policies and procedures with the regulation. This analysis revealed a number of gaps resulting in new procedures, updates to our existing procedures, and Implementation of processes that were not required under cap or CLIA.

We submitted the application along with all required documentation in October of 2014, and the required documentation included any procedures which were cited as proof of compliance and other standard-required documents such as equipment lists, business associate agreements and staff breakdown.

Our A2LA assessment team was assigned and began to perform an offsite pre-assessment of our submitted documentation. In addition an onsite assessment was scheduled in advance for April to ensure that all key stakeholders would be present.

MPLN received the pre-assessment report from the assessment team in March of 2015. This report identified eight deficiencies observed in our submitted documentation, a majority of which were minor items requiring procedural updates and clarifications. For example the report identified that our contingency plan did not include provisions for a cease in laboratory operations. We just don't think about quitting work, and that the organizational structure was not located in the quality manual itself but in a different document. In both cases documentation was updated for compliance. It was also noted that our web-based document control system did not house the required A2LA documents. We included these required documents in our document control system to assure regular review and current updates, version updates. So in April 2015 our initial onsite inspection occurred. Two clinical assessors, an A2LA officer and our quality department, our laboratory director, department managers and other key stakeholders were present during a 3 day assessment. It is rumored that we broke our coffee consumption that week, I know I drank plenty myself. After initial facility tour, the A2LA assessment team conducted extensive document reviews, they examined our standard operating procedures, reviewed our quality management systems, verified all our certifications and licenses and reviewed quality control documentation and documentation practices throughout the laboratory. They also reviewed employee job descriptions, training and competency records and conducted management and staff interviews. Our information system’s infrastructure was thoroughly evaluated as well. On the final day of the assessment 20 deficiencies were cited, many of them were relatively minor and typical to those that we found during a CAP inspection, such as inconsistent reagent labeling or insufficient fiche image retention time, use of date format consistency, those kinds of things. Additionally A2LA required notification of proficiency testing results and changes, and as a response we gave A2LA access to our CAP proficiency testing and instituted a policy that all alternative testing, proficiency testing assessments would be uploaded directly to A2LA. Four recommended observations were cited, one of which suggested that we increase the staff in our quality division to address the increased oversight requirements. Shortly after the initial inspection, we added an additional quality person to the quality unit, with a specific concentration towards information technology and software development end. This person would also perform all other functions within the department such as quality control, document review, internal audits and non-conformance Investigations. Today I'd like to address six deficiencies that had the most significant overall impact to our quality management system and laboratory performance. They fall under the categories of equipment calibrations, software quality and development and risk management.

Three separate deficiencies were directly related to our equipment calibration process. First, our pipette calibrations did not meet the level required by ISO. At the time an external vendor was performing a level 3 calibration, which does not include the range information, of information required by ISO, namely the as-found state and a measurement uncertainty. In order to become compliant with the standard we changed our pipette calibrations to a level 6.

Secondly, employees who are performing in-house calibrations on all other equipment such as timers, centrifuges and scales were not being evaluated for competency. At the time each department was responsible for its own equipment calibrations. In response to this deficiency we had contracted with an additional external vendor to perform the remaining equipment calibrations to the ISO standard.

Thirdly, measurement uncertainty for calibrations were not being evaluated. Outsourcing all calibrations at the required level resolved these deficiencies. However, there was an appreciable cost incurred in doing so. Soon thereafter we began to evaluate other methods of keeping within compliance, but avoiding the significant costs of outsourcing.

The next two deficiencies that were cited on our initial assessment were related to software quality and development, A2LA identified evidence of incomplete documentation of our laboratory information system and the systems with which it interfaced. An investigation revealed that significant improvement was necessary in software development policies and procedures. At the time of the initial assessment we were working on a completely new LIS being written in house by our software development team. As a complex molecular laboratory, we found it’s necessary from the inception of our company to create our own laboratory information system, and in doing so, we had to become more proficient at software program and its documentation

Instead devoting time to revalidate system that was going out of use we decided to focus our efforts on building a new LIS ISO-compliant from the ground up.

Updating and enhancing our software quality assurance plan, software development program and interface validation program took a significant amount of time and resources but ultimately allowed us to build a system with a solid foundation and robust documentation. This is why we chose to add that additional quality person with a focus primarily on software. Because of the initial investment in developing this framework, the new system is now a successful part of our operations.

And finally we were cited for a lack of a formal risk management process. Risk management is not a CAP requirement but globally, but global quality measures are continually moving towards a risk based quality system. We were using our quality action report or QAR, which is our system to record and investigate non-conforming events to evaluate risk retrospectively. Risk was being evaluated during each non-conforming event and we needed to improve, to implement a more proactive approach. In order to rectify this deficiency we developed a risk management process, using the FMEA table. We began our risk management program by applying assessments to the development processes such as new clinical test development, and to the development of our LIS system. Shortly you'll see how this process devolved

So in July of 2015 MPLN received its ISO 15189 accreditation. The accreditation process took 14 months, required only one onsite visit, once accredited we became internationally recognized as ISO 15189 laboratory and can place an emphasis on our accreditation when discussing business relationships with CROs and sponsors globally. However, that's not the end of the story.

Surveillance assessment

Our surveillance assessment, which is our annual assessment, occurred in August of 2016, roughly one year from our initial inspection.

Several deficiencies cited during the surveillance had also been observed during the first assessment. Initially we addressed those deficiencies with training. Upon reoccurrence further investigation revealed the opportunities for process improvement, especially after corporate education on Six Sigma processes and improvement techniques were conducted laboratory-wide. For example, reagents were found to be inconsistently labeled which can be a persistent problem in many laboratories. After the surveillance assessment we ordered custom labels that have blank fields and in Six Sigma languages is called a can ban for all required entities or entries, eliminating the need for employees to remember which entry, which elements are require on a label for each reagent. The technologies in the cited department found the labels extremely useful and we are in the process of implementing this system laboratory-wide. Methods like root cause analysis require out-of-the-box thinking and practice but by really revealing these persistent problems the accreditation process urged us to improve the techniques that we use to address these non-conformities.

Our risk management process was again cited, this time however we were missing a critical element of risk assessment, the evaluation of effectiveness. As a response we revised our FMEA table again to include this element. As a risk assessment is currently completed, a future evaluation date is determined during which effectiveness of all actions implemented will be evaluated by the original assessment team, the team can then decide if the preventive actions have been effective in reducing the identified risk. Preventive actions that are determined ineffective can be retracted and new actions implemented.

In addition to this improvement we find the risk management process to focus on minimizing risk to patient care by directing risk assessments to standard processes within the laboratory, rather than to development processes exclusively. Our current policy is to perform two risk assessments annually on any standard processes within the laboratory, such as the accessioning procedure or a cytocetic process.

Impact on our operations

Some of the challenges we encountered were what seemed to be an escalating cascade of associated costs, ISO accreditation fees from A2LA, new FTE for quality department, increased costs of calibration to a level 6, increase frequency of calibration, etc. We could easily see an increased five-year cost of over half a million for being ISO certified.

So we began to look for solutions and in typical management style looked for several options like building our own metrology functions rather than outsourcing, utilizing excess capacity from other parts of the laboratory, consolidating like work from other areas into a single new role or moving the work to a lower cost labor pool, etc. We also looked at a system that I bumped into while taking Baldridge examiner training when I was in the hospital system in North Carolina. During that training we toured a sign-making facility that ran with a quarter of the staff their competition did because they cross-trained their staff so that when a large order came in, many employees moved to where the bolus (sic) was located. They moved to order processing, to template making, to instrument set-up, to blank cutting, to milling, to engraving. And many of you may remember the famous comedian Sam Kinnison, who had a rant about move to where the food is, and we use this here and rather than level the work in a production line, we move the labor to where the work was. So let's look at what we decided to implement.

We decided to implement them all. I think we're a bunch of overachievers I'm afraid. So let's take a look at the metrology program. We developed, we began to develop an in-house metrology program. This was a big source of the increased cost of ISO-level quality. We interviewed metrology professionals from outside the organization and internal applicants and then chose ultimately an internal applicant. This applicant though naive to metrology was intimately aware of our laboratory operations. Our newly-appointed metrology manager attended an A2LA metrology training program which we found very valuable, which provided him with the tools and resources to bring this process in-house.

This program is almost completed in its development. And at the end of 2016 pipettes are still calibrated by an outside vendor. We are still not quite getting our pipettes calibrated internally, as we have had to buy an additional piece of equipment. All other equipment calibrations are being performed by our metrology manager and the lab assistants are being trained to perform them this year.

Calibration, training and competency evaluations, policies and procedures have all been written and implemented. Calibration of pipettes is almost at a completion now that we have an additional piece of equipment necessary to do so. The new FTE was an internal transfer and that tech’s duties were divided among current departmental staff and certain elements were removed from the Department and added to the lab assistant program.

So let's take a look at the lab assistant plan and where we found staff to cover the work left behind by the new quality department personnel and the tech personnel when they took on their new roles. While seemingly unrelated to our ISO goals, we saw what's known as the bolus effect in our accessioning department and sought a solution that would benefit the challenges across our organization for staffing. The accessioning department has traditionally been staffed to keep costs low. But that resulted in the delay effect that impacted downstream production, which led to later shifts or delays in testing.

We used a lean process evaluation and evaluated a 3 hour to a one day delay in testing, depending on when a specimen arrived, and in bringing on a second shift and later hours just increased cost and reduce employee satisfaction.

I’ll get the slide to change there. So we thought to eliminate all the delays in what Lean calls eliminating the waste of delay by staffing the accessioning department for peak volume, then using the excess capacity before and after the peak times to perform duties left vacant in the lab departments by the staffing of the two FTEs from metrology and quality department. So we have employed four-year-degreed and well-trained and intelligent employees in our lab assistant program to do a number of semi-technical activities in the laboratory, thus freeing the higher-paid techs from those duties. These tasks were varied, encompassing solution making, stocking and set-up of clinical workbenches, shift … shipping and other filing duties, and even including covering the customer service division for peak hour phone calls, which seemed to occur first thing in the morning and just after lunch, and now these laboratory assistants could also be trained to perform all of our calibration and QC needs for our new metrology program. The metrology and lab assistant managers use a system called Rike, a phone app that schedules all daily, weekly and monthly duties to the lab assistant pool and records the completion of the task the instant the lab assistant performs that assigned task. One of the challenges of running a program like this is organization and documentation.

For the metrology division alone there were some upstart costs, most notably in some new labor and training costs. However, once established, the yearly cost was less than half the costs of outsourcing. Additionally, since only a handful of people are performing all equipment calibrations, we reduced the variability associated with too many performing … too many people performing a task infrequently, and as a result, we are producing more consistent and accurate calibration reports. Having an in-house metrology program also allows for calibrations whenever they are needed. For example, if a piece of equipment is malfunctioning, we can address it right away as opposed to sending the equipment out and locating a replacement. If a clinical trial requires a more frequent calibration schedule than the laboratory follows, we can accommodate that easily. Once established, routine equipment checks can be performed quarterly, increasing the likelihood that a malfunctioning equipment is identified early and reducing the possible impact on laboratory operations. This is a piece identified in our new FMEA process described previously. In order to establish the metrology program, we had to review our current systems against the requirements. This led us to uncover that some equipment was being serviced more often than required, adjusting these schedules to fit the requirements ultimately made our metrology program more efficient and saved costs as well. In addition, we have already seen an increase in productivity among the laboratory techs who no longer spend time to perform calibrations or performing routine QC and other tasks, and we have significantly improved the turnaround time as a result, as our specimens are arriving in the laboratory earlier and earlier.

So let's now look at the third item that was significant. The benefits to our software development program have been significant, ISO accreditation has precipitated major changes in software development methods, leading to an increased productivity and improved communication between stakeholders.

Expanded traceability and a more robust documentation has resulted in a more organized process approach to the process, and our requirements gathering methods which is the system we use to collect and organize our software needs has been enhanced to maximize communication between the developers, the stakeholders and customers, promoting the detection and resolution of inaccuracies before they cause complications with subsequent development. A more thorough verification and validation process enables the team to identify bugs before release, resulting in a reduced impact on operations and finally we are steadily evolving to employ a more agile approach to software development, which is a methodology that utilizes short iterations of development and frequent and regular delivery of working software through the effort of self-organizing and cross-functional teams. Frequent releases of software, which has now every two weeks for new versions, assures that our software developers and stakeholders remain on the same page throughout the completion of the project, minimizing rework and maximizing productivity. To stay competitive in our arena with clinical trials, we have to be able to bring on new iterations or new enhancements quite frequently.

Since the implementation of our risk management program, we have started to use a more risk-based approach to systems and processes, resulting in a significant reduction in quality reports in 2016. You can see here, they went down significantly, less than half, I believe. This risk management program not only allows us to predict and prevent nonconforming events rather than reacting to them, but similar to the benefits seen with our metrology program, the process of performing a risk assessment requires a comprehensive examination of a system, thereby revealing hidden areas open to improvement. The risk assessment team is not only analyzing risk but they simultaneously have an opportunity to examine the processes and make it more efficient.

So let's take a look back at the expected escalating costs of adopting an ISO-level quality system. You can see here on the left, the traditional management, our original figures here on the left showed a value of a little over half a million over 5 years. Traditional management style of departmental thinking and budget and cost containment efforts would have had us spending that much. However, by employing an operational global perspective taught by the Baldrige national quality system and together with the techniques of Six Sigma and Lean, and the ISO quality system, has us realizing a significant savings over 5 years, now only expected to be 475,000.

But we have found even more savings since then. During this last year we have had two techs and one customer service person who have delivered children and then decided to stay home with those children, and one customer service person who left for advancement. We again looked at the roles the lab assistant personnel could perform and were able to fill the gaps with a rotational service, saving us even more. This took quite a bit of diligence, to find the roles that our excess capacity in that arena could address. But these well-trained lab assistants have been very valuable for us saving and attritioning additional FTEs.

Summary

So, now as you may already be wondering, none of these changes came easily, for certain. We faced many implementation challenges, the greatest of which was cultivating a culture of acceptance by the staff who would be affected. During this process we used our change management curve, excuse me, our change management curve techniques to effectively listen for ideas and inputs, discuss upcoming changes and communicate the changes prior to implementation. For more on the change management curve, you can look up the previous laboratory leader session on that topic. We took it slow and became trustworthy in some small things, and our techs allowed us to expand the program as they saw us performing trustworthy, for their, for their needs.

As a small laboratory with limited resources, we were able to successfully implement programs that not only kept us in compliance with ISO15189, but also improve our day-today operations. Through the accreditation process we established an in-house metrology program which has improved our equipment calibration strategy, increasing quality and reducing cost. We evolved our software development program and software quality plan to increase the efficiency and reduce work of our software products and finally we developed our risk management program allowing ourselves to proactively assess all systems within the laboratory for risk and opportunities for improvement.

In conclusion, our ISO 15189 accreditation process precipitated a cascade of events that are continuously working to modernize the way that we perform many of our processes and in many ways has made us more efficient and competitive as a laboratory.

Questions & Answers

How does being ISO accredited influence instrument and product purchases?

MR. OLSEN: Well, certainly, every purchase now goes through a risk management assessment. In the past our purchase of equipment was primarily based on operating costs or equipment cost or the need of the industry to look at. Going through an FMEA risk assessment showed us a lot of information about the risks of certain kinds of instrumentation, certain testing equipment that might not be a wise purchase based on the business risk or the calibration risk that it introduced. A lot of … we did a lot of self-calibration of equipment as opposed to having annual agreements, service agreements and having an FME program allowed us to perform our own calibrations on equipment rather than purchasing expensive purchase or service contracts for some equipment. Certainly there’s lots of equipment, you can’t get away with that, but for a lot of equipment that we have, we have the expertise for doing that, that was very good for us.

How involved would you say are all of your staff from lab assistants to biomedical scientists?

MR. OLSEN: In the ISO process, everyone. We are a small laboratory with 90 employees. So a lot of our laboratory employees are, we have small teams working on LIS improvements, they come up with ideas. Anyone who champions an idea for an LIS improvement comes to the team meetings where we evaluate which software pieces move forward, what the impact, what the risk is, certainly you find somebody who says, hey write me a program, that saves me 3 mouse clicks while I’m doing this, but having a risk management approach in those meetings allows us, or an ISO level risk management approach allows them to see why certain things move forward for software development and certain things do not. They are also on the team that checked the software. So when we go through, determining whether the software meets requirements, they're given a script, a written procedure which they then click through and make sure that the software performs to the way they want it to work. We have much higher customer and internal satisfaction because we allow our employees, and almost every single employee in the company does software testing for us. It's really brought people along the curve letting them be a part of the process of improving our laboratory.

Okay, our next question comes from someone with 9 employees and she says how would I go about implementing the ISO value on a smaller scale?

MR. OLSEN: Certainly you don't necessarily have to be ISO accredited and you can do so, but there’s much to learn from the process. Certainly educating your people on preventive error reduction as opposed to reactive error reduction certainly goes a long way. We thought we were good at it until we went through the ISO process. I would probably approach that you have very few people. It's, it can be a documentation nightmare. If you can hook up to one of those companies that provide online documentation management services, there are a number out there. They do a phenomenal job of helping you save a lot of the labor. But I think what you have to do is lead by consistently communicating your sense of vision of where to go, keep people centered on where we're headed. We're headed to the new world, folks, and keep them from getting distracted by some other things. And make it a priority in your organization. ISO risk management probably was the driving factor in a lot of our high achievement in this arena, and I think that's where I would start.

Were you able to reveal the ISO requirements to everyone? Here in the U.K. they specify that only certain staff can see the document.

MR. OLSEN: I'm not sure that we showed the entire staff the entire document. We went through rigorous internal audits, which pointed out the necessary needs. I don't think giving the document to a bench tech serves a whole lot of purpose. But I think the point would be is to conduct the audit and show where you fall short in that audit, and reveal it to the people who do the work. A lot of times the people who do the work are your best idea generators. Those people say, well, here's the problem. Hey, I got an idea. Let's do it this way. This lab A program was championed by one of our managers who was having an increasingly hard time finding staff to run his technical operations and he wanted to divest his team of some of the things that they were having to do: wash glassware, check on the DI water, calibrate pipettes, that were just eating them alive and in time used, and he said, I can save two FTEs if you can find somebody to do all those quasi-technical things. I don't think you have to share them with every employee, but I think you have to share then the general direction and the intent of an ISO level quality system in a way that they can see its benefits.

The next question refers to the labels that you mentioned earlier for reagents, she asked if you could provide an example of the labels you created for the reagents, similar to the can ban cards.

MR. OLSEN: The labels that we chose I believe came from STAT labs very standard label that had open date, expiration date, created date and perhaps one other element on them. The problem was, the reagents coming in from external vendors and reagents developed internally did not have consistent labeling. You’ve noticed that various vendors have labels all over the place, of where all this information was. It was really nice to get this label that was a standard label, it just had 4 empty places for people to put information, and yes it was redundant to rewrite the expiration date, but it added to the consistency when you left a blank that had to be filled in. We just went around and you could clearly see what labels were having a missing element, it was easy for the laboratory techs to survey their own department, turning those labels outward and at a glance, they could see the missing elements.

You mentioned that you had some inconsistent date formatting. Did the labels require a standardized date format?

MR. OLSEN: The labels did not require a standardized date format. Our problem was we were using an American date format and since we were doing so much work and growing so much work with an international status, we had to adopt the European date system, which is date, the day of the month first, then the month which is 3 letters, followed by a 4 date year. Our laboratory people who've been doing laboratory work for 30 years with June 15 comma 2017, had to adopt 15 dash JUN dash 2017 format. That took about a year and a half to get through consistently in our organization, that alone. That was probably one of the difficulties we had, is changing a habit that was so ingrained into the way people do it. It’s really odd now, I go write a check nowadays and I do that European date format almost by rote, just because we had to beat it into ourselves for so long to change that format.

There’s an atrocious amount of paperwork involved as ISO seems so interested in documentation. How is there any way to keep this to a minimum?

MR. OLSEN: You know, that's one of the reasons why the ISO folks, and we also saw the need to increase our quality department personnel because of that. We use, let me think if I remember the name of it. A document, an online documentation service, I’ll think of it here in a minute, that catalogs organizes, serves up required documents to every tech. You can write proficiency exams in it. It's a wonderful tool, I’ve used it at various hospitals and we adopted it several years ago. It's a wonderful online tool that houses all your documents, make sure that each document served up to every employee who that document needed to go to and documents that that personnel has read that instruction, even answered questions or taken a test on those instructions and perform competency for those. The competency program is called Compass, and for the life of me I’m still not coming up with the name of that software program, but a really good system. That helps out, but yes, the new modern world is full of documentation and clinical trials is full of documentation. That was one of our biggest challenges of moving into the new world is just the heavy amount of documentation, certainly a documentation system is probably your primary source for doing that but also is to maintain a focus on what's important in your organization.

There was mention of Lean and 6 sigma principles that you require people to become certified at the various levels of Lean Six Sigma training, such as yellow belt, green belt and black belt training.

MR. OLSEN: No we did not, we primarily focused on a general awareness, because we wanted people to utilize the tools. I have taught tools at each session. You know, a lot of times if you take a class and you don’t use a tool for two or three years, you become stale in its use or you don't recall when it could be used. Certainly, to teach a tool when you're using it is really important. We also during this time hired an industrial engineer whose job it was is to help us evaluate systems and bring about these kinds of changes. He was trained in six Sigma, we didn't all have to have an industrial engineering degree, but he could teach us the principles, the needed benefits of it, and if we had a general awareness of what these tools were and how they worked as background education, which was required, that served a long way. But as everybody served on a team, we serve the tools up, and they found them to be highly valuable when they were looking to evaluate something. If they were trying to decide whether to hire one employee versus another, we pulled out the force field evaluation tool, came up with criteria and evaluated both employees with a force field tool, and then they clearly saw the advantage of one employee over the other, and your team was more centered on accepting that one employee rather than going on fighting about, well, I thought this was more important, after the fact. Use of the tool during team meetings is very important, so having one or two people in your organization on every team meeting who is an expert or very knowledgeable in those tools is probably your best resource

At what level was the CEO involved in leading the ISO change?

MR. OLSEN: Well number one, the job of a CEO is to set direction for the corporation. Certainly what I call relentlessly communicating your sense of vision. The CEO's job is to recruit people to get on the boat with them and sail to the new world but while sailing to the new world, you also have to keep your ship afloat, you have to prevent people from chasing after that white whale or rowing over to that pretty looking island over there. The other part of his role is to consistently be communicating our ISO level quality achievements to business partners at meetings he’s in in Europe or in Singapore, etc. ISO level quality became almost like a backup camera to the car industry, most high level shoppers wouldn't dare buy a car without a backup camera, the modern shopper and the global infrastructure of global testing is shopping for a high quality laboratory, the backup camera or the ISO level quality is just the required element that has to be a part of the installed equipment for you to get the business.

What significant challenges came from the staff? Were they resistant to giving up some of the more traditional tech responsibilities to the lab assistants?

MR. OLSEN: Yes, certainly they were. We had some folks who produced high quality work and they were very reluctant to let a lab aide clean out the incubator, for example. So instead of just telling that lab personnel, hey, this new lab tech or a lab assistant is going to do this for you, we let that lab tech train that assistant. We gave them what's called a smooth hand shake. We used our trust curve, we used the get-to-know-you phase. They spent time with these new personnel, they found familiar ground between them and then they moved from what is called the known to the unknown, and by building trust slowly one person at a time through relationships, through putting people together in rooms, listening to their complaints or their fears. At the same time as those who would be taking those over was very precipitous in moving things along. Yes, it was very difficult at first, but after we began to build some trust, gain some acceptance, perform the task better than what was taught, then they began to believe in it and it moved much quicker.

Has ISO accreditation affected sales either in the U.S. or outside the U.S.

MR. OLSEN: Well we achieved accreditation in 2015, and our fastest growing division, the clinical trial division, was the primary reason for ISO, grew 30 % that year. Now, can we definitely say that ISO level quality was a precipitator in that growth? No. Our customer satisfaction surveys that went out that year did not specifically ask about ISO quality as being a reason for choosing our laboratory. But as I’ve said before, not having a backup camera on your minivan is probably not going to help you sell your minivan. It's probably one of those things that’s just plain old expected by the modern consumer in a high complexity laboratory situation. And so we felt like we had to do it, if we had not, I don't know that we would have grown 30 % and on a course for another 22 % this year in that division without it.

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