Quality Improvement in the Cath Lab from a Process Engineering Viewpoint

Introduction Prior to becoming an RCIS and beginning work in the cath lab, I worked for Hewlett Packard (HP) and Agilent Technologies for 32 years. During this time, I was a certified journeyman machinist, quality inspector, dimensional metrologist, a manufacturing, product, and process technician/engineer, part of marketing teams, and an ergonomic specialist. As part of marketing teams, I was responsible for the division’s worldwide product warranty collection and web reporting process for our division. My career went full circle: from making the parts, as a machinist, to sitting on the teams that analyzed our product warranty failures and then communicated this information back to production and R&D in order to continually improve our products for our customers. By sharing this experience, from different but related disciplines, it is my hope that you will become familiar with a synergistic set of filters you can use to look at and improve a task or processes in your lab. The Quality Revolution: Continuous improvement philosophy The basis for many of the ideas behind continuous quality improvement came from Dr. W. Edwards Deming. Deming’s teachings in quality management in Japan after World War II were very influential in transforming Japan into their present technology leadership role. It goes without saying that Deming contributed to the quality revolution that also affected American manufacturers and businesses. Most likely the manufacturers of the medical equipment and supplies we use in labs today, as well as some labs and hospitals, are using many of his quality improvement ideas. Deming published his famous 14 points of continuous improvement philosophy in a book called Out of the Crisis (MIT/CAES, 1986). I am going to mention a few that, in my opinion, are the most important for this article, with a comment below each point. 1. Create and communicate to all employees a statement of the aims and purposes of the company. Communicate the facility’s goal of a continuous improvement philosophy and the reasons for adopting this philosophy, such as competing well and improving through innovation and research. 2. Work to constantly improve quality and productivity. Always strive and work to improve the quality and productivity of your processes. It is imperative for keeping competitive. This can be a differentiator between you and similar facilities. 3. Strive to reduce intradepartmental conflicts. These types of conflicts are barriers to continuous improvement efforts and communications. 4. Eliminate exhortations for the work force; instead, focus on the system and morale. This process is about evolution and change; adaptation to the changing environment surrounding our field. It is not about short-term gain, but establishing processes that will survive the ups and downs. 5. Remove barriers that rob people of pride of workmanship. Pretty straightforward. One barrier could be micro-management. Give credit where it is due, and remember that process empowerment can instill professional pride. 6. Educate with self-improvement programs. Train employees on the why and how of continuous improvement philosophies and the ways of statistical quality/process control. 7. Include everyone in the company to accomplish the transformation. Everyone is valued, integral and important to this journey. Cooperation is key to making continuous improvement work. Facilities become more powerful and adept as a result of the synergistic influence of the power of all of the employees working together. Negative points of view are barriers to cooperation. Deming felt that the people who work in the process have incredible potential if the atmosphere effectively educates and sustains a sense of responsibility and pride. Vision What is your vision of a world-class cath lab? Is it about the getting patient to the lab, equipment, the speed of time to stenting, the cardiologists, what is delivered to the patient or perhaps all of these things? Once the vision has been decided upon, it must be clearly communicated to everyone involved and broken down to levels that allow a clear picture of everyone’s role. Goals and metrics should be set to move the organization towards the vision. Once this happens, ownership and accountability can arise. Continuous improvement environmental requirements Continuous process improvement requires a strong management presence that is actively involved and has excellent communication skills. That way you will have the support and buy-in to help you have successes and carry-on power for continuous improvement. If your lab has been established for a while and has not been exposed to this way of doing business, management needs to provide the structure and training to make it a reality. (That does not mean that staff cannot advocate for this philosophy, however.) In our factory, goals/metrics were continuously monitored for adherence or deviation. The continuous improvement philosophy was communicated and embraced by the organization. Everyone knew his or her part in the big picture. They were empowered by their ownership of their part of the factory. Driven by management, groups and employees were trained and then empowered to take ownership for their processes. Staff who have not grown up within your lab culture, or who have not been introduced to continuous improvement philosophies in the past, can at times find it hard to see beyond what they perceive as working ‘just fine.’ Job descriptions should detail job responsibilities so there is no confusion on each person’s connection to the big picture. It is also important to note that intradepartmental conflicts and/or poor morale are barriers to continuous improvement efforts. Yet accountability is paramount and commitment is essential, once the way forward has been agreed upon. It is ultimately a personnel performance issue if agreed-upon continuous improvement efforts are not followed to the letter. Consensus is not about total agreement, but agreeing to go along with the plan for the good of the team. I believe this is important to emphasize in the event that management, in the move to a continuous improvement environment, must lead the team somewhere they initially may not want to go. Interruptions to the process In a factory, we call it a line stopper when something happens to bring flow of the line to a screeching halt. You can visualize how a line stopper in the middle of the production line would affect processes before and after the line stopper. Could leaving the room to get a stent, balloon or catheter be considered a line stopper? Maybe; certainly if the x-ray broke down it could bring the case to a screeching halt. Another example might be if a product line received a mixed stock of a mechanical part. Workers could continue on if they could easily identify the difference between the two parts. This would be merely an interruption. Other workers would sort the parts offline so the production line workers would not have to use their time to sort. It is their job to work the process, not sort parts. This same scenario occurs in cath labs when, for example, a product arrives that is different than what was ordered, or the quality has changed. Some thoughts on cath lab processes Following is one picture of a cardiac cath process. This is based on my personal process improvement bias. I have highlighted in bold several process suggestions that I feel would reduce the time needed to do a heart cath. Patient Smith is the next person on the board for a corpos, or diagnostic heart cath with intervention possibility. The scrub, x-ray, monitor tech and nurse have been identified for this case. The scrub tech goes to the adjacent room and picks up the cath bin for this case. It has a sheet specifying the patient and doctor, and any special needs such as radial, different French size system, and wingless introducer needle. It also has the correct info to determine the contrast type. This bin has the cath-pack, the diagnostic catheters, sheath, extension tubing, heperinized saline, bottle of flush liquid, doctors gloves, injector tube and anything else needed to start the case except lidocaine, scrub gloves and betadine. If you use ChloraPrep (Medi-Flex, Inc., Leawood, KS), it could be included in the cath bin. While the back table is being set up, the monitor tech is loading the info in for the case, and the x-ray tech is adding the lidocaine, betadine and giving the scrub tech anything else they need. The table and room are ready to go in a timely manner. There is personal technique involved in all these processes. All labs have staff that seem to be the fastest ones at table setup. Their techniques would be a great thing to identify and share with the staff when time allows. The patient has arrived just as the scrub tech has completed the back table. The team works to safely move the patient to the exam table. Arm boards are installed if appropriate, a blood pressure cuff is installed to quickly provide info to the nurse to determine drug protocol. The EKG tabs and clearly marked EKG leads are quickly attached at their proper locations. During this time, the scrub tech moved the back table adjacent to the patient and then prepares to scrub. The scrub tech has prepped and draped the patient, and the x-ray tech has been helping to get all of the necessary accessories to the procedure table. Scrub tech is ready to go. The cardiologist is gowned and gloved, and the case is started. (I am not going to go step-by-step on sheath, wire handling or catheter handling, because to me, these are individual-driven techniques for both the cardiologist and the scrub tech. As I continue to work in my career, I will strive to improve my skills and speed as well as anticipating the needs of the cardiologist.) The case has started with the FL4. The doctor has successfully cannulated the vessel and taken their preferred views. Next is the FR3.5 for doing the RCA. The doctor is trying to cannulate the vessel, but it seems to have an odd takeoff. After trying several different catheters that are unsuccessful, the team turns and look at a laminated poster on the wall that has full-size pictures of the different configurations of catheters, to help them get another idea on what bend might cannulate this RCA. The team makes another choice, a Williams Right, and it successfully cannulates the RCA. They discover a fixable mid-RCA lesion. The case converts to an intervention. The x-ray tech goes to a drawer at their end of the lab and takes out the inflation kit, nitro/heparin syringes, MD 60, and the 1cc syringe for nitro. The doctor requests a FR4 guide and wire. All of the guide catheters, diagnostic catheters and wires are stored around the same end of the room. All catheters and wires are labeled and stored in such a way to easily access what is needed. The doctor successfully crosses the lesion with the wire, and requests a 2.5mm x 15mm balloon to predilate before placing the stent. The x-ray tech again quickly accesses the requested balloon at their end of the room. There are 2 of each size and most styles. The wire has been wiped by either the doctor or scrub tech in preparation for the balloon. The size is announced to confirm the correct type and size, and then it is presented to the scrub tech. The balloon loop is handed to the cardiologist. The scrub tech keeps the prepping end. As the balloon is being threaded onto the wire by the cardiologist, the scrub tech is prepping the balloon. The balloon is placed at the lesion and inflated. A 3.5mm x 15mm drug-eluting stent is requested. Again, the x-ray tech accesses this stent at the same end of the room. There are two for each size and manufacturer (if multiple suppliers are used). The stent loop is handed to the cardiologist. The scrub tech keeps the prepping end. As the stent is being threaded onto the wire by the cardiologist, the scrub tech is prepping the stent. The stent is placed at the lesion and is inflated. It is successfully deployed and no post dilation is required. The wire is pulled, final pictures and pressures are taken, and the case is completed. As the room is getting cleaned for the next case, it is one person’s responsibility to take any empty balloon and stent boxes to the central storage room and replace the used items back in lab. During the same case, a stock out sheet was marked that the last Williams Right was used. This information is passed on to the material handling person. The team works together to prepare for the next case. The room is cleaned, garbage is thrown away, new linen is put on the procedure table and the next cath bin is brought into the room. Cardiac cases have a rhythm and flow to them, mostly set in motion by the cardiologist. Each has their own speed and preferences regarding how a case is carried out. Here at the Oregon Heart & Vascular Institute, we have several cardiologists that are quicker than others, and speed is very important to them. You know time is important to a cardiologist when they tell you how much time they’ve saved by putting on their scrubs at home (this cardiologist had it figured out to how much time was saved in a year!). Let’s look at each process highlighted in bold, and discuss some barriers/slowdowns and issues to the smooth flow of cath lab processes. 1. Cardiac Case Bin Benefits: Do not have to go to multiple locations to get supplies. It is easy to return items to storage areas because you have not opened packages. It is easy to make several generic bins for add-ons. It is a good idea, if you use this method, to have your cath bin loading area designed so you do not have to travel far to fill each bin. Think about the process before setting up the your central storage room. In the dynamic environment of the interventional lab, this method (versus having multiple cath table setups waiting) would work better because they are specific to the case but generic for all. Diagnostic labs: perhaps you have the room and multiple back tables to set up full tables in the morning for scheduled cases. Now you just roll it into the cath lab, add liquids and scrub tech gloves, and you are ready to go. Barriers: Gathering everything needed for a case from different locations in and out of the room. This is a slower process. A robust material handling process is required for timely replenishing of important items such as stents, balloons, wires and catheters. 2. A sheet specifying the patient and doctor, and any special needs beyond the standard setup, such as radial, different French size system, wingless introducer needle, history and contrast requirements. Benefits: Allows you to have your back table completely set up much faster for when the patient arrives, with all of the needed liquids ready to use. You have the needed information to set up the cath bins for the day. Barriers: Sometimes information is not available until the chart comes in the room. Why? 3. The table and room are ready to go in a timely manner. Benefits: You team is working as a unit to set up the room. Doing this on a regular basis enhances the synergy of the group. It extends to dynamic acute cases when they occur. You can get critical data to the room monitors quicker. Barriers: There is only 1 person left to clean and set up the room in between cases. Items needed for the case are not in the room. 4. Clearly marked EKG leads. Benefits: When the EKG patch end of the cable is the correct color, there is no hesitation or confusion getting it to the correct location. You can get critical data to the room monitors faster, therefore allowing the nurses to do their jobs in a more timely manner. Barriers: When these leads are not marked with the matching color ends and plugs, you must take the time to look at the multi-connector plug to see where the lead goes. If you have your main plug attached under the table, you may have to take the time to look under the table to determine location if they are not properly marked. If you are hooking up a patient who just came to the lab from the ER with ST-elevation, this is not the time to have to slow down to identify the lead. 5. Laminated poster that has full size pictures of the different configurations of catheters. Benefits: Cardiologist can easily compare potential choices in the sterile environment of the cath lab without leaving the case. You can save time. Barriers: Cardiologist leaves the sterile room to look at rack of catheters in another room: A potential for breaking sterility. It takes time. The doctor asks for several catheters so they can look at the shapes. If they are in another area, you must travel out of the room to get them. This is a case interruption. 6. The x-ray tech goes to a drawer at their end of the lab and takes out the inflation kit, nitro/heparin syringes, MD 60, and the 1cc syringe for nitro. Benefits: You can save the time of traveling to different parts of the lab to get the interventional supplies. All of the items are in one easy-to-reach location. One technologist at my facility had the idea to have small reusable trays that contained these items. It could be set on the counter prior to each case. If the case goes interventional, you are ready, if not, it’s easy to return to your storage location. At our lab, we have a rollaround cart that has these items, plus the 6 French interventional guides. Barriers: It takes time to move to multiple locations to get the items. 7. All of the guide catheters, diagnostic catheters and wires are stored around the same end of the room. All catheters and wires are labeled and stored in such a way to easily access the one you need. Benefits: There is no hesitation or confusion when you have to get these items. Again, these items are quickly passed to the scrub tech, thereby maintaining the rhythm and flow of the case. Barriers: It interrupts the rhythm and flow of the case when you leave the room. 8. The x-ray tech again quickly accesses the requested balloon at their end of the room. There are two of each size and most styles. Benefits: There is no hesitation or confusion when you have to get these items. Again, these items are quickly passed to the scrub tech, thereby maintaining the rhythm and flow of the case. Barriers: You have to take time to go to another area to get the balloons. There could be traffic, doors to open or close, or steps to navigate going to another area to get the balloons (stents). It interrupts the rhythm and flow of the case when you leave the room. 9. Again, the x-ray tech accesses this stent at the same end of the room. There are two for each size and manufacturer (if you use multiple suppliers). Benefits: There is no hesitation or confusion when you have to get these items. Again, these items are quickly passed to the scrub tech thereby maintaining the rhythm and flow of the case. Barriers: Cardiologist leaves the sterile room to look at rack of catheters in another room. The doctor asks for several catheters so they can look at the shapes. If they are in another area, you must travel out of the room to get them. There could be traffic, doors to open or close, or steps to navigate going to another area to get the balloons (stents). You need a robust material handling process as well as the cooperation of lab personnel. 10. As the room is getting cleaned for the next case, a designated person takes any empty balloon and stent boxes to the central storage room and replaces the used items back in lab. During the same case, a stock out sheet was marked that the last Williams Right was used. This person also ensures this is refilled so it is available for the next case. Benefits: It is important to practice first-in, first-out, so the oldest items are used first and do not expire. Someone is always held accountable to restock. A teammate reminds them if it does not happen. You are never without the needed items during cases. Note: Having small quantities of balloons, stents, and catheters helps reduce the amount of room these items take up. This requires a group effort. Members of the lab must replace used items after each case and the material-handling program must be stringent enough to ensure that the central storage area is kept stocked. You cannot go to other rooms to pull stock. You will then have one room running well, but the other room can be without needed stock during a case. I believe cath lab design should not only take into consideration its core work, but also the storage and movement of material in and out of the room. Since it should be efficient to do a diagnostic or interventional heart cath, it should also be efficient to store and replace needed material for the cases. There are several types of material handling methodologies: 1. Kitting: what is being used when we receive prepackaged kits based on procedure needs. 2. Con Bon: restock at a set restock level. 3. Keep Fill: a designated person checks at specific intervals. Barriers: If staff take items from one room to restock another, rather than going to central storage. I think this is a robbing Peter to pay Paul type of idea. Eventually everyone pays for this one. This can be a case stopper or cause setup to take longer if someone has to search for the accessories that should have been in the room. 11. The team works together to prepare for the next case. The room is cleaned, garbage is thrown away, new linen is put on the procedure table and the next cath bin is brought into the room. Benefits: It is a quicker process, with everyone working to set up for the next case. You establish and create synergistic relationships that enhance the flow and rhythm of the process. Barriers: The structure and dynamics of the organization does not foster continuous improvement efforts. Final thoughts It is important for the scrub tech and cardiologist to have the back table and procedure table organized in a certain manner for the flow of the case. Items are placed where they are expected to be for every case. Why not extend these processes to the lab layout? For example, there should be one place for wires, organized by diagnostic and interventional, and clearly labeled so you can quickly choose the correct one. Diagnostic and guide catheters should be organized in such a way that it is easy to choose them and you do not have to go to several locations for different French sizes or manufacturers. There are many ways to store items in your lab for easy access and there are many different ways to design a cath lab. You can decide if storage solutions need to be portable because of lack of space and multiple uses for the lab. Don’t let these kinds of things be a barrier to your world-class cath lab. For labs with multiple rooms, relative locations should be the same, and vertical and horizontal layout should also be the same, to help with quick access. It will slow response time if the rooms are set up differently. I do not believe this would be a good idea during acute situations. Anyone new or staffing a circulator position temporarily can have trouble finding needed supplies that are not labeled well or if the rooms are set up differently. Storage of items in a room or central storage should have some forethought. Labels should be facing out or spot-labeled for easy identification. Thin items like wires should not be stacked like books on a shelf without section labeling. It is better if there is separate storage spot for each size catheter rather than stacking different sizes behind each other, so you have to flip through them. If your lab has a number of stock outages which interrupt your flow, you need to analyze minimum quantities, as well as working with your buyer to have delivery information. Par levels set too low may lead to frequent outages, especially on weekend shifts when there may have been multiple interventional cases. Facilities can negotiate with cardiologists to agree on single suppliers (preferred vendors) for stents, catheters, wires, etc. This reduces the amount of stock that needs to be stored and made available for cases. Does your facility really have a continuous improvement philosophy? Is this a regular topic for staff meetings? Does your management philosophy foster and nurture these kinds of discussions and ideas? How do you make lasting improvements to your cath lab processes? Ultimately, it is about care of the patient, and how quickly and effectively we can deliver our services in a quality manner. If your lab receives an acute patient with ST-elevation, and after diagnostics the cardiologist determines there is a directly stentable lesion, will the extra time taken to go to a central storage area make any difference to this person’s heart? Is time really muscle? Finally, I want to thank Dr. Morton Kern for his compliments on my February 2006 Cath Lab Digest article, Cath Lab Ergonomics. I also want to thank him for his comments on the importance of communication during cases. This can affect the quality of the case. While writing this article, his thoughts influenced mine on the importance of communication to start the process of continuous improvement, as well as frequent communication to keep it living and evolving. Communication of your facility’s vision and the underlying values driving your lab processes is just as important as the communication during a case. Both are paramount to the continued improvement and success of your lab. Frequent communication of case flow is as important as communication of your progress on your department metrics. If you do not have the underlying driving values and metrics at the forefront of your department’s and staff’s thoughts, there is a good chance that you will not meet your goals. Al Moglia can be contacted at amoglia@peoplepc.com

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