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Today’s reality and an emerging global trend, is that wellinformed consumers are demanding bold innovations that enhance value, quality and efficiencies with service delivery at the same time that resources and reimbursement models are declining. Having to do more with fewer resources is the new norm. There is general acceptance that successfully adopting and implementing Quality Management Systems (QMS) and related improvement tools results in process optimization, operational efficiencies and value. This highly informative and insightful session will share real world experiences from a 800 bed combined hospital pathology department, including impressive results such as reduced patient waiting times, rapid return on investment (ROI) and improved turnaround times.
- Describe how integrating Lean and Quality Improvements tools drive process improvements resulting in improved patient care, operational efficiencies and client satisfaction.
- Recognize the essential leadership competencies, team attributes and key performance indicators necessary to achieve stretch goals, powerful staff engagement and success with change management initiatives.
- Summarize the competitive operational advantages achieved with adopting QMS and visual management indicators to influence teamwork and creative problem solving through the use of evidence based real time data and dashboards.
Vince D'Mello is widely acknowledged as a leading subject matter expert, key opinion leader and cutting edge thinker in the medical laboratory industry, with a successful track record of transformational change delivery. He has more than 35 years of leadership experience with a variety of laboratory operations and meeting accreditation standards from organizations such as the College of American Pathologists (CAP), American Association of Tissue Banks (AATB) and Ontario Laboratory Accreditation ISO 15189 requirements.
Currently, he is the President of D’Mello LabMed Consultants (DLMC), an independent company that specializes in laboratory systems, operations and strategies. He was most recently Director of Laboratory Medicine at Grand River Hospital and St Mary’s General Hospital in Kitchener, Ontario from 2010 to 2015, where he provided the leadership with several notable and unparalleled accomplishments.
Key Industry Trends and Change Drivers
Needing to do more with less resources is something laboratories constantly have to deal with. At the same time, the strong pressure to reduce budgets, costs, escalating clinical demands, increasing volumes, and case complexity is more prevalent and isunderscored with regulatory and administrative burdens that accompany most laboratoryoperations.It is essential that laboratories embrace the benefits of quality systems. If you are in a leadership position, one of your responsibilitiesis to drivethequality agenda. Once you accept quality as a necessary element for providing a service, you need to appreciate that it's a journey, not a destination. Always look at it as opportunity to learn, improve, and do better for your patients. There are a number of tools availableandyou just have to select the appropriate tool for the situation. Involve your front-line staff to engage with qualityinitiatives. Integrating the clinical, operational, financial, and patient safety criteriais going to be the driver for your best return on investment and something your clients and patients will appreciate. Adopting and embracing quality systems is a stepping stone towards providing evidence-based excellence.
The trend for laboratories to demonstrate value is increasing. For today's discussion the definition of value is achieving quality outcomesdivided by the cost to achieve that outcome. Costs can be defined as price of commodity and the time involved with delivering a commodityor test. Costs can be incurred or avoided.In the lab environment there are opportunities to demonstrate the ability a value-add opportunity. In my experience, the ability to drive quality initiatives that reduce hospital length of stay or unnecessary admissions is something that is appreciated by the executives of hospitals. The challenge is trying to convince the hospital executives that any savings derived as a result of the laboratory's initiative will be reinvested in the laboratory.
I'll use microbiology testing as an example for hospital acquired infections. If you can take advantage of technology where you can provide results in 18 to 24 hours or less as opposed to 2 to 3 days,and if patients are occupying a bed for two to three days because the results are not available, by adopting that type of technology you could provide the results on the same day or within a few hours. Imaginethe amount of savings to a hospital with reducing that length of stay.If you can repeatedly and consistently do the right test on the right patient at the right time and it leads to the appropriateclinical intervention, that is undisputable value and what we should strive for on a regular basis.
On this slide I am emphasizing a few values I thought would help to attract talented people. Find something to laugh and smile about every day in your laboratory, acknowledge that everyone is normal until you get to know them, and finally, accept as a workplace value everyone brings joy to the department, some when they enter and some when they leave for the day.
About Lean & Six Sigma & QMS (Quality Management Systems)
Six Sigma is basically a sophisticated structured approach to help you achieve and sustain organizational improvements. The DMAIC methodology is define, measure, analyze, improve, and control and there are questions you will pose to help you achieve a good outcome. Who are your customers and what are their needs and priorities?How can you maintain these improvements? This is a very structured approach and you need people who can help to sustain and drive initiatives. Six Sigma was used in a core laboratory where the challenge was having consistent turnaround times 24/7. The night shift turnaround times were rapid, the afternoon shift was less rapid, and the morning shift was slow. Over a 24-hour period we had threedifferent turnaround time standards which was not well accepted by the clinicians. By doing a Six Sigma study we were able to make it more consistent and there were no differences. It was a very structured approach to deal with inconsistencies of turnaround times and I'll share with you an example of how it can be used in a hospital environment.
Six sigma starts off with genuine focus on the customer. Its all about the customer's needs and priorities. Data and fact-driven managementis something that's relevant for improving your process. It is proactive management and it helps as stepping stone to achieving excellence. What does Six Sigma mean? At the Six Sigma level it's 3.4 defects per million opportunities. There are many industries, including the airline industry, that do have functions that operate at that Six Sigma level. From my knowledge, experience, and reading, there are several laboratories on this planet that operate between Five and Six Sigma. That is high level of quality.
The laboratory I was in started to present our data using the Six Sigma formula. If you're working with labeling errors, let's assume that you have a 10% error rate, basically 90% is nonconformant. The table on the right you see that at the Three Sigma level you've got a 90% noncompliance rate. In this example we set a target of working around Five, Fourpoint five, and over a year is what we were able to achieve. That was almost a thousand beds between the two hospitals. It was not great quality, not Six Sigma, but working between Four and Five in a hospital environment is considered quite acceptable.
Lean is basically a strategy to eliminate waste and nonvalue added activities for the customer. What are the principles of Lean? Its about providing value as defined by the client and it's about understanding very clearly what the customer wants versus what they do not want. When you start with the Leanprocess the value stream mapping comparing your current state with your future state identifies quickly and easily what is nonvalue-added in the eyes of your client. That is how you're able to drill down to providing value for your client. If you get it all right and sustain improvement,that leads to a certain level of perfection. Errors are also reduced, costs are reduced, space is reduced and good things happen when you have your Lean project under control and it works for you.
When you compare Six Sigma with Lean there are some subtle differences. Six sigma helps to reduce process variations. Turnaround times that vary between three shifts or different days of the week is a great opportunity for a Six Sigma study. Lean is about reducing nonvalue-added waste and processes. If you get into doing a Lean study with primary intention of reducing your headcount, I can guarantee you it will be a failure. That's not what Lean is intended to do. You can embrace Lean without being mean to people. You need your front-line people to identify opportunities because they know where the waste is in their systems. Utilize your staff to identify those opportunities. The biggest challenge with Lean or Six Sigma or any other tool is a human aspect of changed management and never underestimate that important factor. Six Sigma takes months; it’s a very structured process. You need good expertise to help you drive that initiative and you need the time and resources to do it properly. Lean you can do certain studies in just a few weeks or months.
If you want to be successful with Lean/Six Sigma there is a significant amount of change involved for your staff and processes that we are familiar with. Here are some of the principles we shared with the staff of the study. It's about learning, improving, and moving forward. You don’t start by getting great outcomes without going through that process. You have to have a culture in your department where there is zero tolerance for blame and shame tactics. Your customers just want quality improvements and efficiencies with good outcomes. It also comes down to having a team of individuals with a mindset of let's just do it, let's learn from it by trial and error, but the focus is on making it better for your patients. If you use data and evidence to drive your efficiencies you are going to be successful. Avoid seeking perfection at the outset of your project. It takes time, energy, and effort to achieve perfection.
Strategic Leadership, Change, & Improvements
There are four categories of staff in any department. There are people that make things happen, there are those that resist what happens,those that watch what happens, and then those that wonder what happened. They are completely oblivious to all of the changes that are relevant and important for patient care. Just be mindful that in order to be successful with a project you need to have the right skills of staff who can help you drive your agenda.
I was involved in a study with at Grand River and St. Mary's. With the two hospitals there was about 800 beds, about 108,000 emergency visits, 5,000 hospital staff, 180 lab staff, 12 lab physicians, pathology 28,000 cases a year, and 7,400 cytology cases. Using the HSMR benchmark, the mortality rate used in Canada to estimate how good a hospital is with preventing unnecessary death where anything under 100 is considered good, you'll see that both hospitals were well below 100. That's a good sign there is commitment to quality in the two institutions.In the Pathology Department there was a foundation in that this department was ISO 15189 accredited for more than ten years and had a strong foundation and culture for making quality improvements. Leadership of the department were champions with driving quality initiatives and the chief of lab medicine is commended for being such an ambassador for making patient-centered improvements.
Pathology Case Study
The study was the first Lean study for both the hospital and the lab. As result of the study the Grand River Hospital embraced the concept of Lean and business intelligence as part of the hospital initiative. This is a list of pre-Lean issues where we were committed to make changes. There were uncontrolled batch sizes arriving every day and no integration of processes to meet the client's needs. There was pre-assignment of cases to pathologists, constant prioritization or reprioritization of cases, clinicians who were not happy with the service and complained the most got their cases processed faster than the ones that were quiet. There was a need for change as the turnaround times were not meeting client's needs.In Ontario hospitals pathologists are salaried employees of the hospital who get the same scale of pay as it is not a fee-for-service compensation model. Pathologists are not dependent on volume in order to obtain their compensation. There was a culture where the 12 pathologists felt an absolute need to have equity over the number of cases distributed between them over a month or over a year. Some of the pathologists wanted this equity down to the tenth decimal point of equity which posed even more nonvalue-added activities.
Here is a glimpse what the Lean and post-Lean outcomes were as a result of the study. We have an average of 20 cases backlogged today for accessioning. Once we cleaned up the system there was no backlogs. Grossing could take anywhere from 10 to 14 days pre-Lean and even with improvements we never got it down to less than 4 to 5 days. Fifty-two percent of the pathology reports were signed out in five days and over 30% took longer than ten days. Within one year of introducing the Leanprocess, 88% were signed out in five days and only 2% took longer than ten days. You can see it was the same in year two as well. Lean did make a difference in the case of sign-out of reports.
We started off with developing a new vision that was about the patient using a supermarket concept model where the client posts a service. The clinician and the patient looking for a diagnosis would pull from the pathologist. The pathologist needs the slide from the technical staff in order to do the readings, the technical staff need cases that come in from the OR to be grossed and accessioned in a timely manner, and we had to ensure that the specimens collected in the OR and reaching the laboratory were done in a systematic and reliable fashion. The pathologists started to become the pacemakers for the daily workflow. If we received 100 surgical cases a day and the pathologist group signed out 100 cases a day, we were in flow. Input to output means continuous flow and we started a process of first in, first out or FIFO. We set up a system where the pathologists pulled the cases from the supermarket and signed out based on the date that the sample came in.
The front-line staff came up with a goal of 90% to be reported within five days. This particular Pathology Department was strictly a Monday to Friday operation, typically two shifts, 7 am to 7 pm, 12 hours of coverage Monday to Friday. Our Lean study was around redesigning the processes of how we utilized the staff and how workflow was distributed to the pathologists. We needed to eliminate backlogs and nonvalue-added processes and we needed to educate staff about Lean and quality improvements. We also needed to have the ability to transfer knowledge and skills for continuity and to sustain the improvements. We eliminated the pre-assignment of cases to pathologists, went to first in, first out, and the model was based on the three pillars of teamwork, trust, and evidence-based problem solving. Thesystem changes were driven by the front-line staff as they identified what was beneficial for their efficiencies and what could make it better for the patients to get the results faster. It was a pull versus push workflow model that was adopted.
Expected outcomes were achieved and here you can seein this first box on left is pre-Lean and post-Lean. The post-Leanin orange bars shows steady improvement over time and that is a sign we did have success with turnaround times. If you look at all the specimens coming into the Pathology Department the bar on the left is pre-Lean, post-Lean, four days, five days, seven days, ten days. Our goal was 90% in five working days and there was steady improvement as the study went on with about a year and a half of timelines.
This slide shows return on investment. At the bottom you will see we didn’t have a lot of costs involved doing this study. We engaged our staff and used less than 200 hours of staff time and we averaged it out. We avoided costs by eliminating nonvalue-added processes. The main story I want you to get out of this slide is that we were able to add staff from the savings we achieved and we were able to show that we could do that with the savings achieved as part of this study and what we were able to get in savings was less than five months.
Within six months we did a staff engagement survey to see if people were noticing the differences of what's going on and finding it better than it used to be. When you go down to this slide you'll see that the majority of staff saw a substantial improvement. Impacts on turnaround times 75% and marginally improved, almost 100% of the staff noted there was a change with turnaround times. In productivity in operational efficiencies, 63% said it improved significantly, 29% said improved marginally, and if you combine those two, that’s in excess of 90% improvement.My view in life is you've got to spend time on the people who are action-oriented and get the job done. The survey clearly showed there were benefits to the staff with the model we had modified.
BI Applications Benefits/Values
The next few slides are about having the tools to allow you to drive timely improvements in realtime. Turnaround time reports and productivity reports on average were three to four months retrospective and you had to provide explanations to the executives why targets were not met. It was not an exercise beneficial for patient care, and because it was retrospective, it was hard to make improvements that were meaningful and done in real-time.
The opportunity to use a business intelligence application came our way as a result of the study and we took advantage of that. I will share with you some of the benefits of adopting this. The key is real-time data dashboards, evidence-based decisions, proactive issue management, and an opportunity to influence a culture of continuous improvement using real-time data to drive the agenda. When we got involved with business intelligence we were heavily dependent on the IT Department of the two hospitals to help us with our study. The IT Department is inundated with other project and priorities and getting our needs met was not easy. The IT Department people told us the benefits of having a BI application tool latched onto the hospital information system was easy to maintain, there was very little involvement from them, and implementation and validation was less than three months. After it was implemented and our own lab staff became superusers of the business intelligence application, we did not need the IT Department to help us withanything as we were self-serving.
When you get into business intelligence applications there are numerous datasets that are available and you can customize it to your needs. Operationally you can get data related to volume, staffing, and turnaround times. From a clinician standpoint, you can get quality reports, utilization reports, and you can get reports related to quality management systems and accreditation needs. Financially you can get a good sense of your position and how you are coping with your budgets.
Here I will share with youhow we utilized some of the business intelligence applications to make improvements. This slide has to do with core biopsies. This is pre-Lean, that's post-Lean, and our target was 90% in four working days for the biopsies. There was steady improvement for the liver and not so much for the lung. We were doing okay with the breast as breast had a higher priority and more volume compared to liver and lung. With the benefit ofthe business intelligence application we were able to very quickly to get this level of data almost in real-time.
Here is an example of how we used the application to help us understand how we were performing with frozen sections. Our target was 90% completed in less than 20 minutes. Over almost a year we were able toachieve that and these were charts that were available and posted within the department. It became a real source of motivation for the staff involved to see their performance measured and see where improvements were needed.
This slide shows how many surgical samples came in over this week, how many samples accessioned were actually grossed. Here you can see we grossed less than we received but on the next day we caught up and took care of the deficit. In one view using this application, we could see whether we were in or out of control. The bottom shows we only had four pathology assistants responsible for grossing the samples on any given day. We could monitor the productivity of each pathology assistant on a daily basiswhich could explain some of the fluctuations and why we were never in flow. These are the challenges that you need to be able to manage as you go through the system.
This particular slide is about pathologist productivity. This was anonymous information that was done and it’s a depiction of one day when there were nine pathologists available. At the bottom are the number of slides in total that the pathologists read in order to sign out a case and up here is the number of cases that each pathologist sent out. These are then broken down into cytology, fine needle aspirations, and subsets of the various pathology reporting. Here you can see there's a pathologist that only signed out 1 case with about 20 slides as opposed to someone who was highly productive that day. The pathologists set the pace for delivering service to the clinicians. If they received a hundred cases and they signed out a hundred cases on a day we were in flow. If we received a hundred cases and the pathologist only signed out 50 cases then 50 cases went into the backlog. This is something we were able to monitor on a regular basis.
This is another side to show you that accessioning is in control, grossing is in control, and you can quickly tell how many cases came in, accession, and how many were not grossed. This is another great view of when you can manage the workflow. Everyone could see the number of cases that were accessioned, and the number of cases that were signed out. We can see this for a weekly basis and you can tell how many cases were in the system, how many were within five days, and how many were over five days.
As far as the supermarket visual is concernedwe had three color codes. If we were in the green less than 75 cases were 5 days old, yellow 75 to 150 cases at greater than 5 days and red meant that over 150 cases were 5 days old. This was a system that was devised and created by the staff so they could visibly see the differences in the workflow. It also was predictive. If you were in the green on day zero and then you were in the red on day four and no changes were made to staffing, you can almost predict that you would be in the red by the time sign out came on day seven. Highly predictive and skillful way of managing workflow using business intelligence applications.
This is the supermarket I was referring to on a good day. Everything is signed out, here is the oldest cases based on people that need to be dealt with first, here was the rush priority cases and there's nothing there, and here's green which means everything is in control. We had red, yellow, green and behind here was a security camera and that's how we knew certain pathologists were gaming the system and cherry-picking cases. That was one of the challenges we had to deal with.
The benefits of adopting business intelligence applications are that it is a simple tool, reports can be created easily and quickly on a daily basis,and the information is accurateand timely. Changes can be made as required allowing you to be proactive.
Prior to this study a SILO culture existed where the accessioning and technical people were in worlds unto themselves, the pathologist's assistants were only interested in grossing their specimens, and the pathologists were all on different wavelengths when it came to what was importantfor sending out cases. By removing the SILO culture everyone then focused on what was best for the patient. We also were able to ensure that the front-line staff were engaged as most of the improvements were identified and proposed by the staff who knew it best. The outcomes show that the FIFO and supermarket model were more efficient and transparent.
I do not want you to get the impression that everything worked beautifully from start to finish. We did have a lot of challenges and about two years into the new workflow model we started to identify troubling issues. There were deviations in standard operating procedures, there was clear evidence of the cherry-picking of cases, FIFO was not consistently followed, and we encountered significant staffing turnover and changes. We knew from the evidence we needed four pathology assistants a day in order to maintain a flow. There were days when we had one or two pathology assistants and no backup coverage. Things started to unfold and turnaround time targets were not being met. We did a root cause analysis and we had clear evidence that without minimum staffing and without backup staffing for short-term and long-term staff disabilities, we were compromising our study and turnaround times.
What are the key learnings I can share with you as a result of the study? First you need collaboration both internally and externally. The supermarket model is an excellent example of when teamwork is strong. It's built on trust and when problems arise the business intelligence application gives you evidence to make and drive improvements. You need data to drive decisions and plan improvements that are patient-centered. It's an opportunity to have a new experience using quality tools. The staff were happy to undergo the study and happy with the outcomes as well.
If you are going to undertake one of these studies keep the following I mind: You need tools that can give you monitoring of workload and backlogs in real time. It is also critical that you have backup staff and trained staff to deal with workload changes as well as staff shortages. When there are assured measures in the system, having annual across the board budget cuts for your department is not an incentive. We had identified deficiencies, reduced costs, and within a few months we had to give it all back to the hospital because the budget was cut. Remember, what gets measured gets improved.
Quality systems have benefits and your takeaway message should be with respect to Lean and Six Sigma. There is a certain amount of leadership needed to drive the initiative. Its an opportunity to achieve excellence, you need to be action-oriented, and remember the journey never ends. You meet challenges all the time. You want to use powerful data to make the changes and improvements. You have to have a strategic mindset when you set out on these projects and you need to set goals so that people have something to want to be proud about and to contribute to and get engaged in. Measurements and performance measures are critical to helping drive improvements. Remember it’s a big change that needs to be embraced and when you accept that, all of this is worthwhile because it's better for your patients and for your clients.
I will end this session and be happy to take any questions. I appreciate you attending this session and I hope you found it worthwhile.
How was success measured and communicated within and outside the pathology department?
We had poster boards in visible areas of the department which showed all the performance metrics; turnaround times, efficiencies, backlogs, and that was posted internally. Information was shared with the staff at regular weekly and monthly staff meetings and the leadership team of the department provided reports to the executives on a quarterly basis describing the progress of the study. Once a year we described the study to the board of the hospital.
Externally once the information got out that this was an unprecedented study for a pathology department we had numerous requests to present information and our experiences at conferences, professional meetings, seminars, webinars and that was considered a very successful initiative. The staff were consistently thanked for their contribution because it was the department staff that contributed to the successes of the program.
If you were starting over again what would you do differently and why?
They say hindsight is 20/20 and it's always a challenge to try and simplify things. I'll identify three. First, I would have a Memorandum of Understanding with the hospital that once the study is started it will be supported with resources if the evidence suggests that is the contributing factor for disruption to the study. Secondly, I would be a stickler for accountability in terms of ensuring that productivity targets set and benchmarked are achieved. Individuals at all levels of the department would have to be accountable for meeting the targets set for productivity. We had evidence that we had productive and nonproductive staff. The nonproductive staff would have to be coached to get to a level that was standard so we could meet our turnaround time targets. The last thing I would do is as part of the Memorandum of Understanding, any savings or cost avoidance as a result of efficiency improvements would be reinvested in the departmentand not returned to the hospital to balance their budget. That would be an incentive for the staff to keep driving for improvements.
Were all pathologists on site or did you have to consider courier times?
We had a group of 12 pathologists of which 11 were always at the Grand River site. Only one pathologist was at the St.Mary site and they were primarily there to help with frozen sections and do their case management. What's the second?
Were samples collected from offsite?
Yes. From St. Mary's,which is about 3 miles from Grand River, the samples were couriered to Grand River where the Pathology Department was located three to five times a day.
Was turnaround time measured from time accessioned or time received in the lab?
Turnaround times were calculated from the time that the sample was accessioned.
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