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INTRODUCTION Healthcare consumers demand quality in the products and services they receive. They expect nothing less than the best for themselves and their loved ones while using inpatient and outpatient healthcare services. Central Service (CS) professionals must establish appropriate quality level...

INTRODUCTION Healthcare consumers demand quality in the products and services they receive. They expect nothing less than the best for themselves and their loved ones while using inpatient and outpatient healthcare services. Central Service (CS) professionals must establish appropriate quality levels for the products and services they produce, and ensure that these levels are consistently maintained. CS technicians directly serve internal customers (physicians, nurses and other professionals working in the facility). The success of CS depends upon satisfying the needs of these internal customers, so they can best serve the patients. Quality (or lack of quality) can have dramatic consequences on the health and safety of both patients and facility personnel. Providing quality products and services directly impacts patient outcomes and significantly impacts the department's (and the healthcare facility's) success. CS technicians are an integral part of quality service throughout the healthcare facility. CS technicians are now processing medical devices for surgery centers, physician's offices, offsite clinics, nursing rehabilitation facilities, dental offices and third-party reprocessors. With emerging antibiotic-resistant bacteria and the ever- increasing complexity of surgical instrumentation, it has never been more challenging or rewarding for CS personnel to consistently provide quality products and services. This chapter will discuss several established quality indicators to assist in monitoring quality within CS departments. The ultimate goal is high quality patient care. This can best be achieved through comprehensive training programs and ongoing quality monitoring. COMPONENTS OF QUALITY Quality is not a quick fix for healthcare facilities. Achieving world class (best in the industry) quality requires a multi-year plan to move a facility from its current quality level to the ideal (highest achievable) quality. For example, the Ritz-Carlton hotel chain, the only U.S. lodging organization to win the prestigious Malcolm Baldrige award for quality, began its quality journey with a benchmark of 60,000 defects per million transactions. It planned a six-year process to move to 0.60 (less than one) defect per million transactions. The Ritz-Carlton's definition of world- class quality also required a 50% reduction in cycle time (the time that passes between an order being placed and being completed). This planned approach to move toward an ideal quality goal is just as relevant to healthcare as it is to hospitality. Top-level administrators must emphasize quality because their support is critical for success. Most problems affecting the employees' ability to accomplish work are caused by systems and procedures that have, in some way, been required or implemented by toplevel leaders. Departmental quality should be multidisciplinary, as well as intradepartmental. A true quality program utilizes all CS professionals and a cross- section of its customers. Empowerment Empowerment is the action of driving the process of decision-making and implementation down the facility's chain of command. In other words, some decisions that have traditionally been made by managers or higher level departmental staff or administrators are now made by supervisors or front line staff members. Empowerment is typically limited to well defined areas, such as process improvement changes within the employee's defined areas of responsibility. Employees assigned to specific work areas must know how to properly perform all work tasks before they can be empowered. Managers must provide training about the concept of empowerment and they must encourage the sharing of ideas and suggestions that can lead to improvements. Leadership Quality requires committed leaders to help manage the data, plan opportunities, establish priorities and empower people to implement process improvements. Effective leaders define standards to be attained in quality products/services. Those standards will drive the development of strategies that address customer satisfaction and the attainment of the facility's goals. Departmental leaders, including shift supervisors and lead technicians, should be the firstline "guardians" of the quality program to ensure that all department personnel consistently adhere to the standards and priorities set by senior managers. Employees should help their teammates follow established guidelines. This can be accomplished by interacting with new or less qualified staff members, assisting in ongoing training and participating in daily quality control checks. Standard Data Each department must select the data that will be used to monitor its quality processes. Planning Tools and Procedures Quality planning can reduce existing problems and prevent potential problems. It involves: Studying other facilities. How do other facilities deliver each product and service that their patients/customers want? Remembering that the process (not people) is the cause of most problems. Thinking about how to improve. Steps of quality planning include the following: Step One: Identify the needs and requests of the department's customers. Step Two: Identify an ideal process to consistently address each need/request. Step Three: Compare actual steps and outcomes of each process to the ideal outcome (e.g., 100% error-free trays). Step Four: Plan process control activities to improve the system. Step Five: Measure the errors. With a good quality system in place, the number of errors should decrease. Staff Members To have a successful quality program, all departmental staff members must be fully engaged with the program. While management may set the standards and goals, technicians, for the most part, carry out the processes to achieve success. Providing all staff members with a solid education foundation will help ensure they use critical thinking skills on the job. Employees must be empowered to address solutions to immediate problems within their realm of expertise. For example, they should be allowed to stop what they are doing to help another employee. They should be able to enlist the assistance of other workers in problem-solving tasks, when necessary. Also, employees who desire additional responsibilities should be allowed to work on longer- term problem- solving projects. This may be done with the use of cross-functional teams that select a process problem, analyze it, develop alternatives, offer solutions and make implementation suggestions. It is important for senior leaders to recognize superior staff members and teams. Process Management Studying processes is critical because process problems cause errors. If errors are identified and resolved, patients and customers will experience fewer problems. Also, employees will have greater success in consistently delivering products and services that meet quality standards. Some processes commonly studied for improvement are: Instrument set turnaround times. Instrument set accuracy. Surgical case cart accuracy. Inventory fill rates. The highest levels of quality are difficult to attain and maintain. When quality is not emphasized, inconsistent products, service delays, negative patient outcomes and employee conflicts can arise. These problems contribute to higher costs for the facility and the patient, and lower revenues for the healthcare facility. QUALITY CONTROL INDICATORS Purpose of Quality Control Indicators CS quality control indicators are often used to determine how well the department is meeting its objectives. Several quality indicators should be monitored periodically. Some examples of CS quality indicators are: Customer departments receive STAT (urgent) medical supplies within five minutes of request. Only sterile supplies with current dates are available on unit supply carts. Sterilization processes are acceptable, based upon results of physical, chemical and biological indicators. Instrument sets contain clean, functional and correct contents. Patient care equipment and supplies are available and in proper working condition. Instruments are available for scheduled procedures to avoid the use of Immediate Use Steam Sterilization (IUSS). Biological indicators accompany every load requiring biological monitoring. Case carts contain correct contents. ANALYSIS OF QUALITY Failure mode and effects analysis (FMEA) and root cause analysis (RCA) are two widely used methods to analyze issues discovered within quality systems. Although these methods are not always recognized or practiced in their original form, their popularity has continued to grow. Both concepts are important tools that can be used in a quality program. Failure mode and effects analysis (FMEA) FMEA has its origins in the military and industrial fields, and is a method of identifying and preventing problems with products and processes before they occur. The FMEA process seeks to accomplish several things. First, it aims to define the topic that must be addressed (e.g., replacing a hospital boiler), then assemble a group of multidisciplinary staff to identify possible hazards and causes (e.g., poor steam quality, pipe ruptures and service disruption). Finally, the team identifies actions and outcomes for each potential problem. For example, before replacing the boiler, it may be important to rent a temporary steam generator to use if problems arise , so the food service department, OR and CS may remain functional if any of the identified problems occur. root cause analysis (RCA) Root cause analysis (RCA) is a reactive process that uses historical analysis of an adverse outcome to help prevent its recurrence. Assume a washer disinfector pump malfunctioned and caused instruments to be improperly cleaned. Each event after the pump failure would be examined to determine what could have occurred and what can be done to prevent this issue in the future. Another example is the tip of a carbide insert on a needle holder breaking during surgery. All members involved with the set will meet to determine what happened and how to prevent this from happening again. Members of this meeting should be: The surgeon (How was the instrument used?). The scrub technician and circulating nurse (What happened? Was the instrument checked before giving it to the surgeon?). The CS manager and the technician who assembled the tray (What are the set policies and procedures for instrument assembly/testing? Was the instrument properly checked?). Risk manager (usually serves as meeting facilitator). Any other interested parties (instrument repair technician, Infection Prevention personnel). This group will determine what went wrong at each step of the process and determine how to prevent the problem from happening again. RCA is widely utilized in the medical field to examine contributing factors to adverse events. Note: The Joint Commission (TJC) standard LD 5.2 requires facilities to conduct root cause analysis on any sentinel event that is recurring. QUALITY PROGRAM ALTERNATIVES Many CS departments utilize a quality assurance program because it is comprehensive and requires the gathering of data to ensure that a quality 206 product is regularly produced. The number of items not meeting quality requirements is compared to the total number of items produced. There are many quality assurance programs utilized within the healthcare industry. Some of the most popular are: Total quality improvement (TQI) involves measuring the current output of a process or procedure, and then modifying it to increase the output, increase efficiency, and/ or increase effectiveness. TQI recognizes that improvement can occur with an individual, a team, an organizational unit, such as the CS department, or the organization itself. Continuous quality improvement (CQI) is a statistical method to improve work processes. Planning and implementing a CQI program for instrument processing involves the receipt and use of input from decontamination staff, processing employees, clinicians and physician personnel and all others involved in equipment use. This team can assist in identifying where more training is needed (multiple users), where process changes are needed (multiple departments) and what the expected quality outcomes should be. Total quality management (TOM) is an organization-wide quality approach based on participation of all members. The aim is long- term success through customer satisfaction and benefit to all members of the organization and society. TQM requires that the facility maintain its quality standards in all aspects of its business. It also ensures work tasks are performed correctly the first time, and that operational defects and waste are eliminated. The above are just a few of the formal quality programs used in healthcare. Many facilities develop their own quality program utilizing a combination of several of the above programs. As long as the program works for the facility and emphasizes the main focus of quality patient care, it doesn't matter which program or combinations of programs are used. Six Sigma and Lean Six Sigma In recent years, healthcare facilities have begun adding Six Sigma and Lean Six Sigma programs to their existing quality programs. Six Sigma The objective of Six Sigma is to deliver high performance, reliability and value to the end customer. It is a highly disciplined and complex process that focuses on developing and delivering near-perfect products and services in an ongoing quality effort. This process strives to eliminate variations in a product (a tray will look the same each and every time it is assembled, and will look like the same product produced before it), eliminating variations to prevent defects. It focuses on process improvement and variation reduction by use of Six Sigma improvement projects. Two of the processes most used in six sigma are: DMADV (define, measure, analyze, design and verify) process is used to develop new processes. DMAIC (define, measure, analyze, improve and control) procedures monitor and improve existing processes. Lean Lean is a production practice with the key tenet of preserving value with less work (eliminating waste). Eliminating wasteful processes reduces production time and costs. Lean's strength is its fast implementation. Immediate benefits relate to productivity, error reduction, and customer lead times. Long- term benefits include improvements to financial performance, customer satisfaction and staff morale. Both Six Sigma and Lean focus on refining the process while reducing defects to an extremely low rate (less than three to four errors per 1,000,000 products produced). Quality at Work Being an active participant in any quality process helps ensure the solutions generated are workable for everyone involved. Whether the activity involves the CS workgroup or a broader, cross-functional team, taking the time to examine processes and identify opportunities for improvement is worthwhile. The following figures provide examples of some common methods to identify issues and improve quality. where representatives from two workgroups, the OR and CS, identified issues with trays sent to CS and the OR. Using a simple problem analysis chart fostered better communication, captured issues and gave the group information to make changes to improve their processes. Quality Programs and Standards Quality efforts of healthcare facilities are also impacted by external agencies whose requirements must be addressed. CS technicians should be familiar with the following: The Joint Commission TJC is an accreditation organization that ensures quality standards are set, monitored and maintained by member healthcare facilities. It has established many health and safety program requirements for patients and staff using recommended practices and guidelines from agencies and associations, including the Occupational Safety and Health Administration (OSHA) and the Association for the Advancement of Medical Instrumentation (AAMI). Routine and unannounced inspections are used to monitor standards, and each member facility is graded on its performance. TJC requires that any sentinel event be reported and thoroughly investigated to correct the causes. The Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services (CMS) is a government agency that focuses on quality in healthcare, as well as patient safety and security. Like TJC, CMS performs announced and unannounced surveys of healthcare facilities to ensure industry standards and regulations are being followed and maintained, and that high quality patient care is the outcome. National Committee for Quality Assurance NCQA is a nonprofit organization dedicated to improving healthcare quality. The organization is known for assisting healthcare facilities in identifying how to prioritize quality goals and measure them and promote ongoing improvement. The Hospital Consumer Assessment of Healthcare Providers and Systems Survey and Value-Based Initiatives The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) (pronounced "H-caps") is a standardized survey tool. Hospitals utilize survey results to measure the patient's perception of their experience during their hospital stay. Three broad goals shape HCAHPS: 1. The standardized survey allows meaningful comparisons of hospitals from the patient's perspective. 2. Public reporting of HCAHPS results creates new incentives for hospitals to improve their quality of care. 3. Public reporting serves to enhance accountability in healthcare. The Value-Based Purchasing (VBP) initiatives compare a hospital's HCAHPS scores in a baseline period to those in a later performance period. Healthcare facilities that do not reach HCAHPS goals are penalized through reduced government reimbursement. Magnet Status Magnet status is an award given by the American Nurses Credentialing Center to hospitals for quality patient care, nursing excellence and innovations in professional nursing practice. International Standards Organization ISO 9000 is an international standard that companies use to ensure their quality system is effective. This process is believed to guarantee that a company consistently delivers quality services and products. While many healthcare organizations have subscribed to ISO standards, few CS departments have applied or qualified for ISO status. QUALITY CENTRAL SERVICE PROCEDURES Attaining and maintaining high quality CS standards is everyone's responsibility. Every technician should play an active role in the department's quality program. It is also each technician's responsibility to help or report others who are struggling with a process. Keeping the patient as the focus means helping ensure everyone is properly trained and performing at optimum levels while working in the department. Allowing a known defective product out of the department is inexcusable and can be very dangerous for patients. There are several tools that can be used by technicians to help ensure quality is always addressed: Performing departmental audits of each area of the department on a regular basis helps to keep the department and its functions at optimal levels. Audits can be performed by outside departments, such as Safety or Infection Prevention and Control, or they can be done by the CS staff, or a combination of the above. Technicians are a valuable asset to these audits because they know the environment and processes better than anyone else. Following the departmental policies, procedures and processing protocols. These documents were developed to help ensure the safety of all CS department members and ensure that all products produced are of the highest quality. Not following policies, procedures and protocols will result in a lower-quality product (i.e., missing, incorrect or soiled instruments) which may harm a patient. Keeping current with new technology and appropriately sharing what has been learned with co-workers and supervisors. As technology advances, the ability to check work becomes more effective. New products are always being developed to help check for residual blood and protein. Better products are on the market to check for lumen cleanliness, as well as products that help ensure our processing equipment is working properly. As instrumentation becomes more complex, it becomes more important to utilize technology to help ensure quality products are being delivered. Taking an active role in quality improvement processes. CS technicians should take an active role in all process improvement projects. Technicians are very familiar with all department activities and can be a vital asset in helping determine problems and how best to resolve them. Assuming responsibility for survey readiness. As part of the CS team, each person is responsible for keeping the department ready for TJC and CMS surveys. Cleanliness, following set practices and knowing the required information on safety, disaster and department processes is a year-round practice. Adopting a team mentality. Help co-workers and accept help from them. No one is an expert at all processes within the department. Seek help where skills are not as strong and help those who need assistance. Attaining CS certification. Certified technicians know why they perform procedures a specific way. This knowledge of the science behind the practices helps ensure practices will be followed correctly, thus helping ensure a quality product. CS professionals are expected to consistently attain desired quality standards as they undertake their normal responsibilities. While this is a difficult goal to attain, it is a necessary one. CS technicians have a significant role to play in implementing quality within their facilities. They can, for example, consistently follow all of the instrument procedures discussed throughout this manual. They do not, however, work by themselves. They are an integral part of the entire healthcare team. To ensure the highest quality of patient care, all staff members must work together. The sum of all contributions by all personnel in all departments represents the facility's accomplishments. QUALITY IN CENTRAL SERVICE PROCESSING ZONE There are many quality processes that all CS technicians must consistently practice in their daily routine. This section reviews some of these processes on an area-by-area basis within the department. Decontamination Zone Always wear personal protective equipment (PPE) when working in this area to protect oneself, other staff, and patients when leaving the area. Disassemble all items, where applicable, to ensure all instrument parts are accessible for cleaning. Measure chemicals properly. Improperly measured chemicals are not effective cleaners or disinfectants. Load and operate equipment properly. Improperly loaded or operated equipment cannot effectively clean instruments. Follow all written procedures for cleaning and disinfection. Ensure that items are cleaned and disinfected according to the manufacturer's Instructions for Use (IFU). Check processing equipment before use to ensure that it is in proper working order Improperly working equipment can harm staff and patients. Preparation and Packing Zone Check for holes in all wrappers and disposable filters to ensure that they are intact before sterilization. Even normal handling can sometimes cause a small percentage of wrappers and filters to become damaged prior to use. Never use a wrapper, filter or instrument that has fallen on the floor. If this occurs, instruments should be recleaned, and wrappers and filters should be discarded. Use only U.S. Food and Drug Administration-approved wrappers and containers approved for the specific method of sterilization utilized. Always follow count sheets. Even if one has extensive experience performing the assigned task, changes may have occurred to a case cart or instrument count sheet. Remember that patient care personnel require the correct supplies when they are needed. Check instruments for functionality, cleanliness, alignment, proper assembly and sharpness. Failure to do so could result in patient harm. Sterilization Zone Always load sterilizer carts as trained. Improperly loaded carts can result in wet or nonsterile loads. Ensure the sterilizer parameters are set properly for the load contents. This should include proper temperature, exposure and dry time. Always verify physical and chemical indicators after a sterilization cycle to ensure that the process was properly completed. Do not touch sterilized items until cool. Properly complete all documentation including load, biological and implant logs. Storage and Distribution Zone Always follow established pick sheets to ensure that all items are picked and delivered. Ensure transport and case carts are clean and dry before placing items on or inside them. Check product packaging for compromised integrity, expiration dating and appropriate color changes of all indicators. All Central Service/Distribution Zone Pay attention to the job at hand: Excessive visiting or other distractions, like a loud radio, can lead to errors. CS professionals should not do anything they have not been trained to do. They must always inform someone when they are asked to perform a process/function in which they lack training. If a CS professional is unsure about a completed project, they should ask someone to check their work. This is much better than to have an incomplete or wrong item leave the department. If distracted, check the entire project to ensure that it is done correctly. If a CS professional can't perform to a 100% level, they should not do the project. Also, they should not start a project if they know someone else will need to finish it. Recheck all work. The short time required to do so can eliminate an incident in a patient care area. Remember that neatness counts. Always help other staff members. If something appears wrong, speak up. Report inoperative or damaged equipment. Attend as many educational in services, seminars, infection prevention, service technician and vendor-sponsored programs as possible. The more education a CS technician can attain, the better they will become on the job. Always follow the established departmental policies, procedures and protocols. They are in place for a reason. which usually is to protect staff and the patients. Remember that quality is the responsibility of every employee, and every employee must be involved, motivated and knowledgeable if the CS department is to consistently produce and deliver quality products and services. CONCLUSION Quality is everyone's responsibility in The healthcare environment and must remain at the core of Central Service operations. Paying careful attention to all policies, procedures and protocols, actively participating in all quality projects, and helping co-workers are all cornerstones to CS quality. A team based approach to quality can provide measurable results that improve patient care and on the job satisfaction.