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2 by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting Quality Management in Central Service Using a Systematic Approach LEARNING OBJECTIVES 1. Define the terms quality and quality management system 2. Identify the documentation requirements of a quality management system 3. Describe management responsibilities in a quality management system 4. Explain the importance of resource provisions necessary to maintain a quality management system 5. Discuss the need to monitor, measure and analyze processes 6. Describe the use of a quality management system to improve Central Service department performance CENTRAL SERVICE (CS) PERSONNEL AND THEIR HEALTHCARE peers often talk about quality. They know it is important and they understand that it is a concept against which they are frequently evaluated. What is quality, why is it important, and how should the management of quality standards be integrated into the way things are done in CS operations? Answers to these questions are among the topics discussed in this lesson. This selfstudy nursing lesson plan is based on the Association for the Advancement Medical Instrumentation s (AAMI) recently published standard, ANSI/AAMI ST90: Processing of health care products - Quality management systems for processing in health care facilities. ANSI/AAMI ST90 was developed to promote quality process/methods and assist healthcare personnel in the proper application to achieve acceptable reproducible results. OBJECTIVE 1: DEFINE THE TERMS QUALITY AND QUALITY MANAGEMENT SYSTEM Quality can be defined as the consistent delivery of products and services according to established standards. Quality integrates the concerns for customers (including patients and user department personnel) with those of the department and facility. 1 All CS departments should emphasize the establishment of quality goals, and it is This series of self-study lessons on CS topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM), and can be used toward CRCST re-certification or toward nursing credits. Pfeidler Enterprises and IAHCSMM both offer grading opportunities. Earn Continuing Education Credits Online: Nursing Credit: Pfiedler Enterprises will award nursing credit for this Self-Study Lesson Plan. Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP 14944, for 1 contact hour. Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. The certificate of course completion issued at the conclusion of this course must be retained in the participant s records for at least four (4) years as proof of attendance. In order to receive credit you must go to and complete the test, evaluation and registration forms. Once completed, you will be directed to print your certificate of completion. Scoring: IAHCSMM will award credit for this Self- Study Lesson Plan toward the renewal of a CRCST certification. To receive IAHCSMM credit, please visit for online grading (nominal fees will apply). Each online quiz with a passing score of 70% or higher is worth two points (2 contact hours) toward CRCST re-certification of 12 CEs. For more information: For questions or problems about Nursing Credits available for this lesson plan, please contact For questions about IAHCSMM Credit available for this lesson plan, please contact us at or MAY / JUNE 2018 Communiqué 53

3 important to establish and implement procedures to attain them. Adherence to these standards can help ensure the delivery of safe and functional reprocessed medical products and devices to customers for patient use. Quality can be difficult to attain and it involves an ongoing, multidisciplinary team approach to be successful. A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and promoting customer satisfaction. It is expressed through the organizational structure, policies, procedures, processes and resources needed to implement quality management. 2 ANSI/AAMI ST90 is a newly-available resource for establishing a QMS in CS departments. ANSI/AAMI ST90 states that healthcare facilities shall establish, document and implement a QMS and maintain its effectiveness. The standard recommends: 2 Identifying and controlling processes, including those outsourced (e.g., calibration, validation or loaned instruments); Establishing the progression and interactions of these processes; Resolving criteria and methods for measuring effectiveness and control of processes; Ensuring resources and information are available; Monitoring, measuring and analyzing processes; and Implementing actions necessary to achieve results and maintain their effectiveness. If any of the processes are outsourced, they shall also be identified within the QMS. The goals of the healthcare facility and the National Patient Safety Goals (NPSGs) published by The Joint Commission (TJC) are important considerations as a QMS is established. For example, NPSG #7 is: Reduce the risk of healthcare-associated infections. 3 The CS department is instrumental in preventing surgical infections because its personnel are responsible for expertly cleaning, decontaminating and sterilizing the medical devices used on patients. A central focus of this goal is the expectation that all CS staff members wash their hands when crossing back and forth between contaminated and clean work areas. CS professionals are also essential in helping prevent non-sterile items from being presented as sterile in the Operating Room (OR) or other patient care areas. These goals should be shared with all employees to achieve a common commitment to quality and to coordinate efforts. CS personnel should be part of a multidisciplinary team that defines quality and the expectations for its delivery. OBJECTIVE 2: IDENTIFY DOCUMENTATION REQUIREMENTS OF A QUALITY MANAGEMENT SYSTEM. Documentation is an integral component of every QMS. This documentation can be in any format (e.g., printed, electronic) and should include: A quality policy with objectives; A quality manual with the scope, references and an outline of documentation structure; Required procedures by industry regulations, guidelines, standards and recommended practices; and An outline of the documentation structure. Maintenance of established records is necessary to provide evidence of conformity to departmental processes, patient safety practices, and QMS requirements. The healthcare facility should review and revise forms, ensure records are legible and retrievable, and define a record retention program according to the healthcare organization regulations. OBJECTIVE 3: DESCRIBE MANAGEMENT RESPONSIBILITIES IN A QUALITY MANAGEMENT SYSTEM Management shall provide verification of their responsibility to the development, implementation and effective maintenance of a QMS. Managers should communicate the importance of patient safety by meeting the statutory and regulatory requirements, establishing a quality policy, conducting management reviews and ensuring the availability of resources. CS leadership personnel shall ensure the quality policy reflects the purpose of the department, including the need to comply with requirements and maintain the effectiveness of the QMS. The policy shall also indicate the direction used to establish quality objectives, as well as a timeframe for review for continued suitability and applicability. Quality objectives relevant to the functions and levels within the department/organization need to be established. The objectives shall be specific, measurable, actionable, realistic, timely and consistent with the quality policy. Responsibilities and authorities must be defined, documented, assigned and communicated within the department/organization. Managers are responsible for ensuring personnel have independence and given the authority necessary to perform their assigned tasks. Appropriate communication processes within the department/ organization should be established in connection with departmental goals and organizational strategic plan goals. The communication should include the 54 Communiqué MAY / JUNE

4 NURSING LESSON PLAN effectiveness of the QMS and may be part of regular management review meetings. Maintenance of inputs, outputs, decisions, and action items should be reviewed for the program. The usefulness and competence of the QMS shall be reviewed routinely (e,g., at least annually). A quality management representative should be appointed for the responsibility and authority over processes needed to carry out the quality policy and procedures. The representative should report to the management team on the performance of the QMS and any needs for improvement. The QMS representative should be the liaison with external parties on QMS matters. OBJECTIVE 4: EXPLAIN THE IMPORTANCE OF RESOURCE PROVISIONS NECESSARY TO MAINTAIN A QUALITY MANAGEMENT SYSTEM Managers should ensure job descriptions are created and maintained for each position; this includes identifying the required skills to perform job functions where lack of such skills would adversely affect quality. Job function shall be defined and measures for providing education and training shall be established, documented and maintained. Employee education shall include a clear understanding of the quality policy and quality objectives, in addition to an explanation of the effects and outcomes of job performance on QMS. CS managers are responsible for ensuring all employees have the skills and training required to do their jobs, including their ability to follow the mandatory requirements established by the healthcare facility and CS department. Employees and their immediate supervisors shall create a schedule of education and training needed to develop the required skills for job performance. Management should ensure sufficient The work environment should promote personnel safety, minimize environmental contamination and maintain the sterility of processed items. Any identified unsafe condition should be evaluated for formal corrective action and be included in the management review. infrastructure and resources are available to conform to requirements, including processing equipment, supplies, storage facilities, equipment maintenance, utilities and transportation of material or devices between facilities, if necessary. Regardless of the location performed, processing activities must meet applicable regulatory and accrediting agencies requirements and recommended practices, including but not limited to: Cleaning and decontamination; Assembly and packaging; Use of process monitoring devices (physical, chemical and biological indicators); Sterilization; Disinfection; Transportation; Storage of sterile products; and Environmental controls. The work environment should promote personnel safety, minimize environmental contamination and maintain the sterility of processed items. Any identified unsafe condition should be evaluated for formal corrective action and be included in the management review. The work area facilitates effective medical device processing by providing sufficient lighting for personnel to complete the tasks, specified utilities are available, and the climate controls can comply with processing standards. Provisions shall be in place for inspection and testing of equipment, and a preventive maintenance program should be established according to the manufacturer s instructions for use (IFU). The scheduled maintenance and repair activities shall be documented and readily retrievable. Additionally, dress code, health and cleanliness requirements for personnel shall be established and maintained. OBJECTIVE 5: DISCUSS THE NEED TO MONITOR, MEASURE AND ANALYZE PROCESSES An important part of QMS is the need to develop and implement a process to monitor, measure, analyze and improve processes. Monitoring tools should include customer satisfaction tools, internal audits, control of nonconforming processes, devices and/or equipment. Management shall take steps to eliminate the causes of nonconformities to prevent recurrence. The healthcare organization shall identify and implement changes necessary to ensure and maintain the continued appropriateness and usefulness of the QMS through the use of: The quality policy; Objectives; Internal audit results; Analysis of data; Corrective and preventive actions; and Management review. OBJECTIVE 6: DESCRIBE THE USE OF A QUALITY MANAGEMENT SYSTEM TO IMPROVE CENTRAL SERVICE DEPARTMENT PERFORMANCE Imagine that a CS manager has received numerous complaints, including feedback MAY / JUNE 2018 Communiqué 55

5 on quality assurance forms from the OR about an insufficient number of available instrument sets, other sets that were not processed in a timely manner, and still other sets that were either incomplete or did not meet quality standards. With cooperation from the OR director, the CS manager forms an ad hoc committee with OR and CS staff to discuss the issues related to the complaints and to formulate action plans to address them. This committee serves, in effect, as a quality management team whose members are to identify, observe and measure the issues affecting instrument set production. Assume that the delays in instrument set reprocessing are found to be caused by frequent washer malfunctions, which are affecting the quality and quantity of work produced. Sets are not completed in a timely fashion because the assembly and sterilization processes are being delayed. As a result, sets that are needed urgently are being taken by surgery staff to undergo immediate-use steam sterilization (IUSS) because they are not fully processed (packaged and terminally sterilized) when needed. Available records indicate that the washer is more than 10 years old, and has thousands of recorded cycles. The team recommends that the washer be replaced, and an approved instrument washer vendor is asked to make a comprehensive site visit and present a proposal for a new washer. To build a case for the new washer, the team agrees to record washer breakdowns and obtain copies of the unit s service history. These relevant facts are presented to facility administrators, along with equipment service life expectancy information (benchmarks) from the original equipment manufacturer. Customer impact statements and CS staff observations are also included to build a strong argument for the purchase of a washer. After administrative discussion, there is consensus for approval and purchase of a new unit. Arrangements are made with the vendor to deliver a new washer and remove the older one. The vendor installs and tests the new unit and finds it to be working within the manufacturer s specifications. Mandatory inservice training about the use and cleaning of the new washer is scheduled and it is placed into service. The concept of a QMS continues as the team monitors washer performance, sets reprocessing goals, records achievements, and reports findings that compare the quality and quantity outputs to earlier benchmarks. The new washer will have adequately addressed the problem to the extent that there is a reduction in IUSS incidents, and in related instrument set complaints from surgical customers. CONCLUSION Although AAMI is a voluntary organization, their standards and recommended practices are universally considered a major resource of healthcare guidelines in reprocessing, and noncompliance is cited by regulatory organizations that inspect healthcare facilities. ANSI/AAMI ST90 provides an excellent resource for all CS managers that should be used as quality management systems are planned, implemented and evaluated. Attaining quality management goals requires the efforts of all CS employees. Quality is a concern of all stakeholders within the healthcare facility and it should be viewed as a multidisciplinary shared goal. Patients deserve quality outcomes and they are becoming active and informed participants in their own care; therefore, CS departments should closely monitor industry trends and be aware of improvements in order to address changes within the field. Education and the ongoing use of a QMS are key to attaining and maintaining the high standards that are necessary for positive patient outcomes. REFERENCES 1. International Association of Materiel Management. Central Service Technical Manual, 8th ed. Chicago, IL; 2016: ANSI/AAMI. ST90:2017 Processing of Health Care Products Quality Management Systems for Processing in Health Care Facilities. 3. The Joint Commission National Patient Safety Goals Effective January Chapter_HAP_Jan2018.pdf. Accessed February 26, Communiqué MAY / JUNE