The Sterile Processing Factory Goal: 100 Percent3

The Sterile Processing Factory Goal: 100 Percent ³

By John Kimsey and Jim Barton

In today's healthcare environment, two seemingly conflicting concerns exist reducing operating budgets and providing quality patient outcomes. While many healthcare professionals see these as being at odds with each other, they don't need to be. Even with today's budgetary constraints, there are solutions that can simultaneously offer hospitals lower costs, improved efficiency, and improved patient outcomes.

One such solution lies within the foundation of quality control process management. It is through effective process management that companies throughout the world have realized lower costs while increasing quality. For today's healthcare executives, it is important to understand process management, and one of the best examples to learn from is a typical factory floor. If you're thinking that hospitals are not factories and patients are not products, you are right, to a point. Using the term "factory" seemingly de-personalizes the patient/healthcare worker relationship and changes the focus to producing a product rather than caring for a human being. However, the hospitals central services (CS) department can combine the best of patient-care practices and process management techniques to improve their level of quality outcomes while simultaneously lowering their costs.

Before explaining how process management can improve the level of service a CS department provides to the operating room (OR), it's best to start by defining the three basic customer requirements of the OR, which can be simply stated as 100 percent^3. The OR requires instruments to be:

• 100 percent complete

• 100 percent clean and sterile

• 100 percent on time

Every CS department should strive to meet these requirements. They are identical to the three quality objectives found in many of todays modern factories: providing a product to the customer that is complete, meets all functional and quality specifications, and is delivered on time. In fact, there are many similarities between managing a modern day factory and running a CS department. Both a factory and a CS department require the management of a process that produces a finished product according to customer requirements, both must minimize the variability in their process to ensure predictable quality outcomes, and both must be able to adjust to changing customer requirements.

Considering the recent publication of "Running a Hospital Like a Factory, in a Good Way," by Andrea Gabor in The New York Times, and the congressional debates on healthcare costs (including discussions of hospital strategies to reduce costs and improve quality using manufacturing techniques), the time is ripe to fully understand the benefits of a factory model in todays sterile processing world.

The Elements of Factory Production

Manufacturing is defined as a process by which raw materials are transformed into a product. How well you control the quality of the materials and the process by which they are transformed determines how well you meet your customers requirements. Whether youre supplying a widget or a doctors preferred instrument set, the rules of the game are the same. There are five basic elements of factory production that every CS and OR manager, supervisor, and employee should understand:

1. Raw material quality control
2. Process flow design
3. Quality management through process control
4. Asset management
5. Order-based processing

Raw Material Quality Control

The old saying, "What goes in must come out, can be translated as: the quality of the raw materials received directly affects the quality and cost of the finished product. Raw materials such as soiled instruments received from the OR must be inspected for quality after each procedure and be documented against pre-determined acceptable quality standards. Too often, hospitals look only at the CS department for process improvements and ignore the impact of OR activities on the process. How well the OR handles soiled instruments and transports them to the CS department directly affects the departments ability to effectively reprocess the instruments and meet the goals of 100 percent³. Comparing this to a factory process, it is now common practice among manufacturing and service companies throughout the world to implement minimum quality standards and inspection processes for incoming raw materials, to help reduce cost and improve quality.

For hospitals this step is slightly different in that the end-user, the OR, is also the raw material supplier. OR staffs often feel they should not be accountable for poor instrument quality. This type of thinking is seen in hospitals where the CS department and the OR do not work together as a team and thus are at odds with each other. To move beyond this, many hospitals have structured their organizations so that the CS department reports directly to the OR. By organizing the entire reprocessing loop (from the OR to CS and back to the OR) under one reporting structure, management can break down the barriers to process and quality control.

OR staff should send soiled instrumentation to the CS department in a consistent manner that supports optimal instrument reprocessing. Proactive hospitals now require the OR to return all instruments that were pulled for the procedure to the CS department in their original containers and with signed count sheets documenting the instruments returned. When receiving the soiled instruments, CS personnel should document any conditions that are non-conforming, such as instrument trays not returned to containers, instruments not properly wiped clean, and instruments not returned to their tray in the correct manner. Hospital staff should document in writing and agree to the instrument preparation standards for which the OR is accountable.

Once inspection begins in the CS department, quality reports can be created to chart the ORs performance. Quality issues can be ranked from the most common to the least common, and the ranking can provide direction to management as to which issue should be addressed first. For example, the evaluation can document missing instruments and which operating room or technician signed off for those instruments. Too often, the instrument sets that are returned to the CS department are either mixed with other instrument sets or missing some instruments altogether, causing additional labor and time to reassemble the set. Remembering that the quality of the final product is directly affected by the quality of the raw materials received, the OR should not view this responsibility as an attempt by the CS department to reduce its own workload. It is actually an important part of a team effort to improve the quality and efficiency of instrument processing and increase the productivity of the OR.

Process Flow Design

Process flow can either support or hinder a factorys productivity goals. The linear assembly line approach pioneered on a large scale by Henry Ford at the turn of the century and the improvements to this approach implemented by Toyota still offer the best guidance to todays factory managers. Process flows must be designed to support the operations objectives while being flexible enough to react to ever-changing customer requirements. Whether they involve assembling a minivan, delivering an overnight package, or reprocessing a large ortho major tray, process flows must be designed with clearly definable and measurable process functions and must support quality improvement and documentation requirements. They must minimize product and employee movement and effort and maximize the use of automation and IT support.

Most importantly, they must support the customers ongoing requirements and involve employees in the continuous improvement process. Process flow design and control are critical to the success of instrument reprocessing. In order to design a flow that supports the operations objectives but is flexible enough to react to ever-changing customer requirements, CS managers should consider the push and pull methods used in manufacturing.

The Push of Decontamination vs. the Pull of Assembly

In the push method, materials and workload are forced as quickly as possible through the process based on a first-come first-through policy. Push flows do not take customer demands into consideration. In the CS department, the push method is best utilized in the decontamination area, where the objective is to remove biohazardous material as quickly as possible to improve reprocessing outcomes and reduce safety hazards to personnel. The decontamination area should be staffed to accommodate the daily arrival pattern of soiled instruments and to process them as quickly as possible.

Once the instruments have been pushed through the decontamination process, the assembly technicians can apply the pull method to prioritize their work according to customer demands. At this point, they have the option to choose which instruments to process and thereby pull them through the process to best meet customer demands. Unfortunately, most CS departments have little information available to facilitate the prioritization and pulling of instrument sets. This lack of information often results in a randomized assembly process. It is also important to remember that assembly is often the bottleneck or capacity restraint within the processing flow and is often understaffed or staffed at the wrong time of the day. For example, a review of multiple CS staffing schedules showed that during a typical day the OR produces more soiled instrumentation between 9 a.m. and 6 p.m. than the CS assembly department can handle.

This leads to a backlog of instruments in the assembly area, causing the department to rely on third shift technicians to complete the work. In order to effectively pull the ORs instrumentation through the system to meet surgical needs and improve the CS departments ability to complete trays on time, CS departments must balance their staff according to the arrival pattern of the soiled instrument sets. If your CS department is frequently dependent on the third shift to complete the days reprocessing, its ability to proactively meet the needs of the OR will begin to deteriorate to a purely reactive state.

Keeping the push and pull methods in mind, CS departments should design their process flows to meet the following process requirements:

• Effectively handle soiled instrumentation according to the arrival pattern from the OR

• Efficiently prioritize assembly of instrument sets as required by the OR schedule

• Accurately measure product and process quality, reprocessing backlogs, and department throughput and productivity

• Balance the process evenly to avoid large backlogs

• Minimize product and employee movement through the department

• Efficiently segregate non-conforming product, such as incomplete instrument sets, from conforming product

• Utilize IT solutions to reduce process variability, improve quality outcomes, and measure performance

• Provide process flexibility to meet changing customer requirements.

Quality Management Through Process Control

Process control, or shop floor control in factory terms, is a common function in the manufacturing and service environment but is rarely applied within hospitals despite its potential benefits. To ensure quality, every step of the process flow must be controlled using documented and measurable standards. Process control is the means by which process quality standards are maintained. ISO-9000 guidelines, Statistical Process Control (SPC), Six Sigma, Total Quality Management (TQM) and other business ideologies and programs all strive to guide organizations toward product quality through controlled and predictable work processes. For the CS department, this means that instrument reprocessing should be monitored and measured against pre-determined standards so that nonconforming product and process variations are identified at each step. The use of information technology (IT) systems facilitates control of the process and provides management with the necessary information to successfully identify and correct process issues.

If real estate agents follow the dictum of location, location, location, then process control advocates live by measurement, measurement, measurement. In order to understand process variability and to control it to predictable levels, every process should have documented procedures, work instructions, and customer-defined quality expectations. The process is then monitored, measured, and evaluated against these standards. Variations in quality and performance are identified through process breakdown evaluations and improvements made.

Without measurement, process performance is often unknown, uncontrolled, and unconnected to the customers expectations. As they have in other process-related areas, manufacturing and service companies have led the way in developing and implementing quality systems such as Six Sigma, LEAN, and ISO 9001 guidelines. It is only recently that hospitals and CS departments have begun to recognize the benefits of embracing similar standards. CS departments should begin by documenting their work processes to understand how well the process meets customer expectations for producing a quality product in a predictable manner.

Process measurements should then be implemented to highlight how well the department and employees adhere to the process. In short, the hospital must say what they do and do what they say. Many hospitals have started down the path of process control by writing excellent policies, procedures, and work instructions, only to find that their implementation fails. Once central service processes are documented and procedures are written, CS managers must then implement continuous follow-up practices that include statistical measurements of process performance.

This means that management must be on the floor observing actual work practices to ensure that employees are following procedures. Managers must also periodically review performance against measurable standards. For CS departments, these standards should relate to how well the process is meeting the 100 percent 3 goals.

For example, the easiest place to start is with the standard of 100 percent complete sets. Instrument sets should be identified immediately at each step of the process as either complete or incomplete. Missing items should be identified, along with where in the process they were lost. Management can then begin to identify the major process obstacles to producing complete sets and can address those issues specifically. Other examples of quality management include: measuring incoming material quality, measuring quality of assembly, segregating conforming versus non-conforming product, measuring assembly errors, tracking sterilization effectiveness, and measuring on-time delivery of product. For every process, management must find methods to ensure that employees are producing quality products as well as completing the required procedural steps. Besides on-the-floor observations, managers can use checklists and sign-off sheets to ensure and document that process activities are being completed by employees.

Asset Management

Within every process and manufacturing operation, the goal of the asset management function is to keep the equipment running and the employees productive. Successful process management ensures that all assets are utilized while maintaining operating efficiencies. Keeping the machines and people going is half the battle. The other half is ensuring that they are running efficiently. This requires management control, effective training programs, and continuous review and feedback. In some CS departments, managing your assets has meant nothing more than controlling employee productivity, and the methods for tracking or planning for productivity has varied from sophisticated barcode tracking systems to no method at all. There is significant room for improvement in this area. In manufacturing, one of the first assessments completed on a production line is an evaluation of whether or not the line is in balance. Line balancing refers to matching the capacity of each step of the process to adjacent steps or processes in the line. In the CS department, line balancing is achieved by balancing the available capacities of the decontamination, assembly, and sterilization functions while meeting the production demand from the OR.

In numerous hospital assessments performed by SterilTek professionals, for example, the production capacity of the CS departments washer-disinfectors and sterilizers was found to greatly exceed the capacity of the assembly technicians working between the disinfection and sterilization processes. While many CS managers are concerned about their equipment keeping up with the demand from the OR, they often neglect to address the growing backlog of work in the assembly area. SterilTek consultants have observed numerous CS process flows that show capacity variations of 100 percent or more, meaning that one step in the process can handle twice as much, or more, as the other steps. This imbalance causes waste in the over-capacity areas and backlogs, clutter, and late deliveries in the under-capacity areas. Ensuring that employees are productive is secondary to balancing the line. CS managers must review their process flows and the required quality outcomes to determine whether or not their assembly area is the proper size and is staffed appropriately at the right time of the day.

Order-Based Processing

The fifth element brings the entire process together by focusing on customer orders as the driving force behind the factorys output. When the customer wants a blue widget, the focus should be on making a blue widget and not a red one. If the OR needs five ortho major sets tomorrow, the focus should be on preparing those sets. Todays factories prioritize their work to meet the customer demand. Japan has taken customized manufacturing seriously. They have designed and created automobile assembly lines so flexible that they can change over from one car model to another in weeks. Since American car makers used to take months or years to change an assembly line, Japan gained an incredible advantage in meeting the customers demands by focusing on achieving an order-based manufacturing process. Federal Express has also focused on order-based processing by creating a process that could handle overnight package delivery to virtually the entire United States no matter where the package originated. Like CS functions, FedEx does not always know what packages will be handled tomorrow, but they do know that the customer has high expectations and they must be ready to meet them. FedEx has also implemented technology solutions that enhance their customers experience and improve the package handling process. Today's healthcare information systems technologies allow CS departments to combine the pull methodology of assembly with IT software that prioritizes required instrument sets based on the OR schedule, to create their own CS order-based processing solutions.

Today's CS Departments

Today's hospitals have not yet realized all the benefits possible from implementing process improvement practices from the manufacturing world. The CS factory will not and cannot operate effectively unless it applies the production methods that companies around the world have already used successfully. For instance, recent capital expenditures by CS departments show the current trend toward implementing instrument tracking systems. While tracking instruments can improve management effectiveness and provide valuable data, many hospitals have implemented tracking systems in response to a crisis and not as part of a complete CS management plan. Additionally, CS departments built more than 10 years ago are now struggling to keep up with growing surgical volumes. Additional future growth in surgical procedures cannot be supported by the current limited CS capacities without overhauling CS methodologies. By implementing process control through factory production methods and active hands-on management, CS departments can better maintain their ability to provide sufficient service to the OR.

When reviewing your CS departments effectiveness, it will be helpful to ask:

• Are you actively running the sterile processing process or is the process running you?

• Are you reacting to quality issues and current OR requests, or are you building a process to proactively meet changing OR needs?

• How often does your CS department provide instrument sets that are complete?

• How often does your department provide instrumentation that is clean and sterile?

• How often does your department provide instruments on time to the OR, when and where they are needed?

• If your facilitys goal is 100 percent 3, now is the time to embrace the elements of factory production process control

Jim Barton, director of operations and senior consultant with SterilTek, Inc., a subsidiary of STERIS Corporation, has 33 years of healthcare experience in equipment sales and the design and development of OR and CS departments. He has successfully designed and built a number of off-site surgical instrument reprocessing facilities. He has been recognized by the American Institute of Architecture (AIA/AHA) for work done with graduate fellowships and student design charrettes, a teaching and learning program for future healthcare architects. He has served on the AIA, Academy of Healthcare Architecture Graduate Fellowship Student Charrette and Vendor Advisory committees. John Kimsey serves as senior professional services consultant for SterilTek, a subsidiary of STERIS Corporation that specializes in process improvement and management consulting. He works with hospitals nationwide to improve their CS operations while supporting future OR growth. Kimsey has more than 20 years of professional consulting experience in the healthcare and other industries. He has worked with Fortune 500 companies such as GE and Standard Products, and with regional corporations. He has led efforts in process improvement, capacity planning, organizational development, cultural change, operational consolidation, financial analysis, and overall financial and operational improvement.