Case Studies

Introduction

 

The tools of Lean Six Sigma were applied adaptively with members of the Management and Staff of a Cardiac Catheterization Lab in a large Hospital. Over a period of about 6 months many small and large incremental improvements were made resulting in increased Patient Satisfaction, reduced stress and complaints from Doctors and Staff and a potential increased effective capacity worth $ millions of additional Contribution Margin each year.

Yet the project reached a pre-mature and unsatisfactory setback just as the results were accumulating.

Out of this experience came the development of the Challenge – Invention – Sustainment model of Adaptive Lean Six Sigma. Learn more about some key experiences applying the familiar tools of Lean Six Sigma with a higher degree of integration toward improving a complex system.

“Apto:” To Adapt

The ideas of a Challenge, Invention and Sustainment cycle are applied here in a retrospective way to a recent Hospital project. This way of thinking about process improvement goes beyond the DMAIC (Define- Measure – Analyze – Improve and Control) or PDCA (Plan – Do – Check –Act) models that are already frequently applied. It introduces Systems Design to support and empower these more locally useful methods.

This Systems approach, brought to life in a local Work Group is the heart of what I call AptoLean. “Apto” is the Latin word for “to adapt”. The idea of AptoLean is to adapt work processes incrementally and continuously – primarily at the Work Group Level but always in the context of the larger Value Stream System demands and top down driven requirements. This Adaptive Process Improvement Model consists of three mutually supporting functions: Challenge, Invention and Sustainment. Generally, the initial focus is on the development of a well formed Challenge – a specific desired condition at a chosen time in the future. This Challenge becomes the starting input for the Invention function. During Invention various experiments take place that develop the know-how, the technological bridge from the “As Is” state to that desired future. As a working solution emerges the function of Sustainment begins, improving on the initial version to provide results that last.

Simple enough in concept. More difficult in application. Not surprisingly it is usually about learning by doing. In this Cardiac Catheterization Lab (CathLab) project I was about to do and learn a lot. Making sense of that learning leads to an explicit understanding of this Systems Design approach for Adaptive Lean Six Sigma. Although the setting of this story is a Hospital it is not really about Hospitals. It is about people finding better ways to work together. As such it can apply to people in organizations everywhere. (pdf version)

 

CathLab Overview: Dealing with Heart Blockages

Many hospitals provide services based on Cardiac Catheterization. You may already have some familiarity with this process. Essentially a tube is introduced into a patient’s artery, often in the upper thigh, and then this tube is carefully snaked along the artery and to the heart. Once there it can be used for both diagnostic and treatment techniques. Often radiographic dye is introduced to the heart which can show blockages in blood flow and other issues in real time. If the condition warrants, a balloon can be positioned to open up a blood vessel. This can then be followed by installing a stent, a tiny wire cage kind of device, to keep the blood vessel open.

Interestingly, the patient is most often awake throughout the process, having been given some sedation and a local anesthetic only. It is quite an impressive experience to be in the control room area, watching the procedure happen through a window while also seeing the patient’s heart beating live on an LCD monitor. Most impressive of all is the care provided by Nurses and Doctors. They have an outstanding ability to keep the patient calm and attended to while playing what amounts to a sophisticated version of a video game with the patient’s beating heart!

These techniques have replaced much more risky and invasive ways of treating certain kinds of heart ailments. Even after the use of the balloon and stent, most patients are out of the hospital the next day and back to improved normal routines shortly thereafter. In the case of Myocardial Infarction (MI), the classic “heart attack”, the patient can go from the edge of death to back home again and symptom free in less than 24 hours

 

Work Process Flow Blockages

As usual in processes everywhere, the near-miraculous can be surrounded by the near-disastrous.

Actual procedures in the CathLab are embedded in a larger system. Patients originate either as admissions on the day of the procedure or as In-Patients from a Nursing Unit. There is a Prep process that includes checking the latest lab tests, consent forms and other documentation and administering some pre-procedure medications.

 

The Patient is then moved to a Holding area adjacent to the CathLab treatment rooms either in a wheelchair or on a stretcher. Next stop is the operating table in a Procedure Room. Catheterization procedures can range in length from less than 30 minutes for diagnostics to an hour or more for interventional procedures. Sometimes the procedure can take considerably longer due to the particulars of the situation.

Once off the table and onto a stretcher the Patient spends time in the Holding area. About 45 minutes is normally spent insuring that the patient is stable and that the site of the catheter insertion is problem free. Some patients move back to the original Prep area and are later discharged. Others will be moving to a Nursing Unit to stay overnight, or longer in some cases.

That island of incredible technology and care maintained during the CathLab Procedure is always subject to troubles and storms brewing just upstream and downstream. While the Doctor and Nurses are focused on the blood flow and function of a  Patient’s heart, it is the flow of information, supplies, patients and available beds and equipment that determines how well the CathLab itself functions. Adaptive Lean Six Sigma can help move such processes from the edge of failure to better health essentially by helping the people in the process to find, mitigate and eventually prevent painful process blockages and delays.

(pdf version)

 

Symptoms: Where does it hurt?

Certain aspects of the daily routine in any process in any organization can result in pain. The pain can affect the clients as well as the staff and Managers of the process. These symptoms are sometimes tolerable enough that nothing is actually done to understand and prevent them. When they do become so painful that something has to be done the response is often limited by the time pressures involved. Providing immediate temporary relief supersedes the finding of a more effective and lasting remedy.

Where is the pain in CathLab Processes likely? You don’t have to be either a Rocket Scientist or an Interventional Cardiac Surgeon to understand where the pain might happen. Here are just a few:

• Physicians can be delayed in getting scheduled cases started. This means they have to plan to do fewer cases than they might like each day. It can mean they will be working late into the evening and missing yet more time with their families or have less time to get ready for the next day.
• Patients can end up spending a long time in the Holding area. Before the procedure this becomes just more time for anxiety. Their family members are waiting outside and experiencing their own worry and anxiety. After the procedure there is actual physical discomfort. Stretchers are intended for use for only a short time. As the hours go by they do not provide the comfort that a regular hospital bed can.
• As the actual process departs more and more from the schedule the Nurses and other Staff in the area are also subject to increasing stress. A full Holding area carries the threat of having to stop procedures in the CathLab. As patients become more and more uncomfortable the Staff has a lot more to do to mitigate the complaints that arise.

Where to start the improvement efforts? There is a saying in Lean Six Sigma that no matter where you do start it will always seem like the wrong place. A CathLab improvement effort can start with an initial direction from the Executive Level to fix a problem. This can be triggered by profitability analysis combined with complaints from Doctors about using the CathLab.

There are at least three versions of any Process issue:

• What Management thinks are the problems
• What people doing the work think are the problems
• What the Process, including the Value Stream, tells you are the problems

The “Go and See” principle followed by analyzing carefully any relevant data is the best way learn what is really going on. This is a key part of forming the Challenge.

 

The Challenge Function

“Go and See” : Using the “Chalk Circle”

Effective Doctors and Nurses know to begin by actually looking at the Patient carefully and intently. Similarly, a great place to start when the “Process is the Patient” is to spend time carefully observing that process. Write a prescription for the “Chalk Circle Exercise” for every Process Owner and a double dose for yourself. Taichi Ohno, who is often called the “Father of the Toyota Production System”, started his protégés off by drawing a chalk circle on the factory floor and then assigning the “Newbie” to stand in that circle for 8 hours – no note taking, no phone calls, no attempt to change anything – just stand there and observe. The CathLab Director – the Manager with the ultimate responsibility for what goes on – starts by doing just this. An hour or two will do observing is a good start – just observing, no attempt fix everything at once.

It has a dramatic impact. There are many painful things to watch going on. Most of these things are rarely discussed at staff meetings or documented in the official reports.

Some important questions to keep in mind when in the Chalk Circle:

• Who is the client and what is the value added for them?
• How is the value interrupted? How often?
• What happens when the value is interrupted?
• How does the working staff know what to do?
• What stops the staff from doing their jobs?

In the CathLab, the patient is obviously a client. But then, so are the Doctors who bring their patients to the facility. They expect to be provided with a place to do their own work effectively and without problems. For both, the value can be interrupted by glitches small and large – missing lab results, consents not signed, a Physician’s lead garment (to shield from the X-rays in use during procedures) not hung in the usual place, etc., etc. In reaction to the initial glitch a series of workarounds can be triggered, using up more time and disrupting future processes as well.

 

“Go and See”: Map the Process Flow:

The Chalk Circle is by definition a static exercise. Next is capturing some of the dynamics of the Process: the movement of “Flow Units” and the flow of information and decisions that determine this movement.

Success in the CathLab depends primarily on the flow of both Patients and Doctors into and out of the treatment area. This flow also directly affects the success and stress level of my main client: the CathLab Director, the Process Owner.

 

Downstream

During an observation session I notice how every location in the Holding Area is filled. The Procedure process is moving faster than the Holding area can find places for these patients. I ask about this. I learn that there is a specific Nursing Unit where most of the Patients are headed and they have no beds at the moment. Time to go to that Nursing Unit to see what happens downstream from Holding.

I meet the Nursing Unit Director (the Nursing Unit Process Owner). She’s interested in improvement and I meet some of the Nurses. I soon witness the importance of the Nursing Unit Discharge Process. I see Patients ready to go home, dressed, with their ride out front in the car with the motor running — and yet they can’t leave. The MD hasn’t signed off on the Discharge – because the MD is currently in the CathLab working on someone else’s heart or back at the office or off doing a dozen other things. Meantime, there’s a CathLab Patient back in the Holding area waiting for an empty bed on this unit.

It’s clear we can’t begin change with the CathLab processes. We have to start by working on the Discharge Process. Any improvement upstream of this Nursing Unit will only lead to more Patient time waiting in the Holding area for a bed to become available!

 

And Upstream

Back in the CathLab I notice Patients waiting for extended periods of time before getting to the Procedure Room. I start the “5 Why approach?”. Some of them are waiting for documentation and test results to get straightened out. Consent forms are a problem. Especially if they are not filled out before the pre-process medication starts. This medication contains sedatives which may affect whether the person can actually give consent. I ask where the Pre-Procedure processes take place and go and see that. There’s plenty going on there – including many workarounds to cope with missing information and out of date lab results. More things to include in the improvement challenge.

 

A Value Stream Flow Problem

Summarizing to this point – what we have is a Value Stream with flow problems. Removing delays prior to the CathLab Procedures will add more delays after the Procedures.. The flow of Patients and Doctors into and out of the Procedure Rooms is also critically dependent on the flow of information (consent forms, lab results, etc.). Now, I look for data to characterize the situation with some numbers

 

Data

After witnessing the view from the Chalk Circle the CathLab Director is even more intent on improving the situation than ever. We discuss the overall Value Stream flow and it is easy for the Nursing Unit Director to begin moving forward. We also start recruiting core team members – key working staff that will be actively responding to the challenges that are being formed.

The CathLab Director begins finding the data to show us the issues in more depth. “Go and See” is crucial yet the right data can say more about what happens over time – where the process is centered, the variability and trends. Just as Nurses and Doctors combine observation of a patient with careful review of diagnostic tests and other metrics, so too we combine looking at the process directly with finding numbers to tell the rest of the story. The CathLab focus becomes four important metrics:

• Procedure Room Turnaround Time: “Toes out” of completed Patient to “Toes in” of the next
• First Case Start on Time %
• Minutes/Patient in Holding time post Procedure
• % Patients arriving to Pre-Procedure holding with all required documents and test results

Initial baseline data is available electronically  for the first three items. The fourth requires setting up a manual tracking sheet. Consistently implementing this tracking becomes another problem to be solved. In each of the four there is plenty of room for improvement! Specific goals are set with a timeline of getting there within six months.

Meanwhile, the Nursing Unit Director and I look for the right metrics to get people to work together to improve the Discharge process. The focus becomes some “Cleaned Bed” data that comes from the Housekeeping Management function. Looking at the Nursing Unit as a Supplier to the Cathlab – they supply Empty Beds – the Critical to Cathlab feature is not really the time of day of Discharging a patient. It is more important when that bed is available for the next Patient. After the Patient leaves, the Housekeeping cleaning process converts an empty bed to an available bed.

Eventually, we begin to shape the Challenge for this Nursing Unit to be matching the pace of “Empty to Cleaned Beds” to the pace of Patients completing procedures in the CathLab who need a bed. The basic “physics” of this situation results in shaping this specific Challenge:

“How do we create Clean Beds at a pace of two beds every two hours from 8:00 AM to 6:00 PM, Monday through Friday?” This means a schedule like this:

• 8:00 AM to 10:00 AM:     Two Discharges and Two Cleaned Beds
• 10:00 AM to 12:00 PM    Two Discharges and Two Cleaned Beds
• 12:00 PM to 2:00 PM    Two Discharges and Two Cleaned Beds
• 2:00 PM to 4:00 PM    Two Discharges and Two Cleaned Beds
• 4:00 PM to 6:00 PM    Two Discharges and Two Cleaned Beds

If the Nursing Unit and Housekeeping can keep to this pace, then the amount of excess Patient Holding time post-Procedure will be minimized. It is also better for Housekeeping, as it levels the demand for Cleaning throughout the day instead the existing of peak in demand late in the day.

This way of thinking about the Challenge will eventually lead to fundamental changes in the way the Nursing Director structures this Nursing Unit and in the way of signing off on the Discharges.

 

The Invention Function

The well-formed Challenge then becomes the input to the Invention function. Invention is the actual Adaptive part. It is motivated by looking at the existing Process in light of the Challenge and beginning to see what an Ideal Process would be like. Then you confront the obstacles that are right in front of you along the path toward that Ideal. Adaptive Experiments take place quickly to test possible countermeasures. There is an overall belief that the only real obstacle is a lack of understanding of cause-effect relationships and that every experiment is part of finding those relationships.

The Challenges are developed at higher levels than the working Staff of a process – but the Invention phase is dependent on those who know work in detail. Orchestrating this phase is work for the Adaptive Lean Practitioner along with the Process Owner and a small Core Team from the Staff.

 

Nursing Unit

The ultimate Ideal Process on the Nursing Unit would be to always have an empty, cleaned bed available just as a Patient is leaving the Holding area post-Procedure. This ultimately means matching the pace of the CathLab by getting Discharges and Empty Beds every two hours as described above. The most immediate obstacle is getting the week started on the right foot.

 

Monday, Monday

The CathLab winds down Friday afternoons. Only Emergency cases happen on the weekends. So, we can have immediate impact on Holding Hours by starting Monday mornings with 10 empty beds. Then the first Patients from the CathLab will be able to flow to the Nursing Unit as soon as they are stable and available to move. We can reduce stress and provide more effective care both in the CathLab and on the Nursing Unit.

In the existing Process, Mondays often start with few empty beds. To make matters worse, many of the patients occupying beds are not fast trackers like a typical CathLab Patient. They can be in a bed for multiple days. We work with Bed Management and quickly get agreement on the logic of what we want. It’s easy to see how the flow will be improved.

Keeping empty beds on a Nursing Unit can seem like keeping water out of a submarine with a screen door. Early on we succeed on some Mondays while other weeks it falls apart due to other priorities and sometimes just lack of communication to the Staff in Bed Management. Yet, over the weeks, even without the new “10 empties on Monday Morning” working all the time, the measured hours per Patient in Holding starts to come down. This proves that this experiment is worth moving further toward Sustainment.

 

Re-inventing the Discharge Process

Empty beds on Monday morning gets the week started. Now, how to keep Discharging at the same pace as CathLab Procedures throughout the week?

Here’s some of the more important things on the Discharge checklist:

• Doctor Authorization
  • Based on: Physical exam, Lab tests, condition of catheter site, etc.
• MedRec: reconciling Medications
• Home Care Instructions
• Completion of the Electronic Medical Record
• Home Care Nurse (if needed)
• Ride Home
• A Place to go if home isn’t an option (a Care Facility)

All this assumes that the Patient is fit to be discharged. Some Patients will not be because they need more time to heal.  The real problem for this project are Medically fit Patients who can’t leave because the Discharge process isn’t fit enough to let them leave! Even better, we need a process that is fit enough to Discharge fit Patients at a rate of two every two hours.

One of the first things heard is essentially “well, you know how those Doctors are”. Soon it is clear that it is not Doctors in general. Some Doctors have difficulty discharging early in the day and some do not. All Doctors will have problems being in two places at the same time, however. So, you can’t be doing a Procedure and also be on the Nursing Unit to sign off on the Discharge at the same time. Or if you are back in your Office seeing new Patients you can’t be in the Hospital doing Discharges at the same time either.

It takes a while but the problem begins to be solved one piece at a time. Some Doctors agree that an Advanced Practice Nurse (APN) can examine the Patient while the Doctor reviews the chart and lab tests (available electronically throughout the Hospital and even back at the Doctor’s Office). With input from the APN the Doctor can make the decision to Discharge. The advantage: the APN will work for the Hospital and be much more readily available. The Doctor can do his or her part without making a special trip to the Nursing Unit. It takes some time, but an APN is hired and it begins to work. Once other Doctors see the effectiveness of this approach and the time it saves they also convert using the APN.

Hospital-wide improvements to the MedRec process during Admission begin to save time in the Discharge Process. Other system changes simplify the time it takes a Nurse to update the Electronic Medical Record. Certain checks that are needed for long stay patients (for example, Physical Therapy) are not needed for those who stay 24 hours or less.

The Nursing Unit also begins planning the Discharge sooner with each short stay patient. The improved routine provides the Patient with an estimated time of Discharge the evening before so that it is easier to co-ordinate getting a ride. Many inventive ideas arise about providing transportation to Patients who have a problem with getting a ride early in the day.

 

The Interventional Unit

Progress leads to more progress and more invention. The Nursing Unit Director holds ongoing dialogue with the Nurses. An idea emerges that becomes known as the “Interventional Unit”. The concept is based on thinking about the needs of “Short Stay” overnight Patients typical of the CathLab Procedures versus the other patients on the Unit who stay multiple days.  Putting a Nurse in charge of Patients from both categories creates a conflict. The overnight Patients require simpler routines. The longer stay patients often require more complicated treatments and care. One Nurse sums it up: “I can do” fast”, and I can do “slow” but I can’t do “fast” and “slow” together as effectively”.

The idea arises of placing all the CathLab overnight Patients together on one side of the Nursing Unit. Over a weekend this simple change is made. A few Patients are moved and by Monday morning the ten empty beds are now all in the same hallway. Two Nurses are assigned – 5 “Fast Track” Patients each. The Nursing Director watches carefully how things work. After a few days it is clear that, using the existing methods and procedures, it is a difficult assignment at times. There is pushback, a desire to revert back to the previous arrangements. Instead of going back, The Nursing Unit Director insists on finding what routines have to change to make the Interventional Unit work and find ways to improve them.

At the same time, this means the requirement to hold ten empty beds each Monday morning is even more important. The Interventional Unit is especially disrupted by starting the week with multiple day patients in those beds.

 

Meanwhile, back at the CathLab…

 

The Interventional Unit approach begins to alleviate the Holding hours problem. Progress on Room TAT belongs to the CathLab itself. First Case start on time issues involve both the CathLab and the upstream Prep Process. All documentation and tests complete and ready for the Procedure is a Prep Process responsibility.

 

First Case Starts

There are four or five Cases scheduled to start at 7:00 AM most days. The data shows many hours of delays to these each week. Not only does this impact those first cases but the disruption cascades onward throughout the day leading to the CathLab Staff and the MD’s working late into the evening.

The “Five Why’s” links the process symptoms (effects) to particular causes. Cases don’t start on time because the Patient isn’t ready. Why? Lab tests are out of date or missing. Why? Lab testing not done before date of Procedure. Why? Doctors’ offices not getting this set up. Why?…

Repeating these kind of questions relentlessly points toward places where small changes can have big effects. Here are some of the more important ones that are found and utilized:

• Match Staff hours more closely to Patient needs – for example, need more Staff earlier in the day to improve starting First Cases on time
• Develop relationships with Admins at Doctors’ Offices and work with them to insure tests results and other needed documents are all available before Patient arrival.
• Make sure Patients have clear directions for finding the Hospital and where to park.
• Encourage Patients to get testing done at the Hospital itself prior to Procedure day – results are then immediately available from within the Hospital system.
• Get Doctors to the Procedure Room on time – alert them 10 minutes prior by phone or text
• As the CathLab improves First Case on time make sure Doctors know they can no longer plan on being late themselves.
• Arrange lead shielding for Doctors so that it is easy to find
• Re-arrange stocking of supplies to minimize searching and having to leave Procedure rooms during a procedure
• Improve shutdown of CathLab each night to make startup easier in the morning
• Special visual coding of Lab Specimens for quick turnaround for CathLab Patients

 

Over a period of 5 months these incremental improvements resulted in a 95% reduction in minutes of delay to First Case Starts and have a positive impact on starting the remaining cases on time throughout the rest of the day as well. This has a positive impact on Patient and Doctor satisfaction as well. All of this was accomplished mainly by a few people working improvements on a daily basis with a minimum of additional meeting or implementation time.

 

Arrivals from Prep Area

Error free arrivals to the CathLab from the Prep Area were another of the four main metrics of the Challenge on this project. This means a Patient arriving prior to the scheduled procedure with Consent forms signed, current Lab tests at acceptable levels and other documents. Smooth handoff at this point is critical to starting cases on time as well as to minimize Patient anxiety prior to the Procedure.

These types of handoffs are a Connections problem, the second of the four rules of Process Design articulated by Steve Spear and Kent Bowen after extensive study of the Toyota system. It is the idea of Jidoka, Japanese for “quality at the source” meaning errors and problems should not be allowed to propagate to the next person or the next work station. It is typical of processes everywhere that the immediate response to an issue is a workaround cycle. Once the immediate issue is overcome there usually isn’t time for contacting the upstream Supplier to start preventing the next occurrence.

The improved approach involved starting a checksheet at the arrival station in the CathLab. The purpose was to generate both baseline and tracking data to determine the effectiveness of various countermeasures. Over several months this data indicated a reduction of arrival issues to near zero at times, although variations continued. It remained difficult to insure a consistent approach to recording the occurrence and nature of issues as well and so the tracking was at times problematic.

The amount of improvement shown by this sometimes incomplete data was attributed to improving routines in the Prep area, especially in being more pro-active with Doctors’ offices in emphasizing the need for Consent forms and Lab results on a timely basis.

 

Room Turnaround Times (TAT)

Another focus of this project was to reduce the time between a Patient leaving a Procedure Room and the time the next Patient is moved into the room. The delay in the physical cleaning of the room was reduced by better co-ordination with the Housekeeping staff. Teamwork among the CathLab Staff was also improved resulting in more than a 25% reduction in TAT. These preliminary results could certainly be further enhanced with a rigorous application of the essential of SMED (“Single Minute Exchange of Dies) from the world of Lean Manufacturing techniques. This means involving all Staff members in developing and performing what are essentially “NASCAR Pit Stop” methods which emphasize a lot of teamwork to get the race car, or in this case, the Procedure room back into action in the minimum of elapsed time.

 

Results and Return on Investment

The accumulation of the many incremental improvements increased the effective capacity of the Cathlab by well over 20%. This is worth many $ millions of increased Contribution Margin each year. Patient and Doctor complaints about delays and confusion were reduced. Doctors had less reason to think about leaving and were being encouraged to bring more of their Patients in.

This was accomplished with minimal extra investment of time beyond my own, the Nursing and CathLab Directors and just a few of the working Staff. Much was accomplished over the 7 months the Project was active.

 

Sustainment Phase – some delays possible

As the various changes, small and not so small, began to generate real impact there was a change in emphasis by the Executives involved.  My time with this project came to an end. There are many ways to explain this. Most importantly, the approach described here was unfamiliar to the upper level Leadership. They had expectations of  a Command/Control oriented approach like the Six Sigma DMAIC model. With no previous experiences in Hospital improvement I had been reluctant to make estimates of savings potential which generated concerns.   Understandably, a downturn in Patient volume overall shifted Executive interest more toward budget performance and away from building additional capacity for the future. I was in the right place, with most of the right tools — just at the wrong time. I learned a lot about Hospitals and Hospital people, as quickly as I could – just not quickly enough.

I read recently that when Lean Six Sigma arrives organizations form into three camps. The Executives see the short term Return on Investment opportunity. The Lean Six Sigma Practitioners see a chance to tryout all those tools they’ve been learning. The people doing the work just keep trying to get through the day and hope the latest “Program” isn’t too much additional distraction.

The model of Challenge – Invention – Sustainment is actually a way to bring all three groups together and get past the naïve assumptions and wishful thinking. It is about working the issues and dealing with the real “physics” of what it takes to improve work. I often term it “Facing Reality Together”. We did a lot of this in the CathLab Project and I look forward to doing more of the same in the future.